Conduct of Study. The Study will be conducted in accordance with applicable laws, rules, and regulations governing the conduct of clinical trials and pertaining to investigational drugs, generally accepted good clinical practice and the conditions specified in the Statement of Investigator, U.S. Food and Drug Administration (“FDA”) Form 1572, as described in 21 Code of Federal Regulations (“CFR”) 312.53, which Institution and Principal Investigator shall have signed and Institution shall have returned to Sponsor prior to the commencement of the Study. Institution acknowledges and agrees that it is responsible for (A) the actions, performance, and conduct of the Principal Investigator, and (B) Principal Investigator’s compliance with all of Principal Investigator’s obligations set forth in this Agreement. Any failure by the Principal Investigator to perform or satisfy an obligation herein shall be considered a breach of this Agreement by Institution. Institution agrees to use its reasonable efforts to ensure that the Principal Investigator complies fully with the terms of the Protocol. In the performance of the Study the Institution specifically represents that it shall, and shall require the Principal Investigator and all employees engaged in the performance of the Study to: a. Exercise independent medical judgment as to the compatibility of each patient with Protocol requirements; b. Obtain from each patient in the Study and before the Study subject begins participating in the Study a signed informed consent form in a form which has been approved by the IRB/EC and reviewed and approved by Sponsor in accordance with the Protocol and with 21 CFR Part 50 and/or the International Conference on Harmonisation Guidelines for Good Clinical Practice as adopted by the FDA (“ICH GCPs”), as applicable Institution will allow Sponsor and/or their respective designees to inspect signed informed consent forms or make photocopies thereof during monitoring visits or audits conducted in accordance with the terms of this Agreement ; c. Properly perform and direct the Study in accordance with applicable laws, the Protocol and ICH GCPs and FDA GCPs; d. Ensure that all advertising, recruitment, and training materials developed by Institution, Principal Investigator, or any of Institution’s employees, affiliates or agents in connection with the Study will comply with the Protocol, as well as all applicable laws, regulations, codes and rules, and receive prior review and approval by Sponsor and the IRB/EC, as applicable; e. Review all patient case report forms (hereinafter “CRFs”) to assure their accuracy and completeness, and assist Sponsor’s representatives and clinical monitors upon request in promptly resolving any discrepancies or errors on CRFs and in performing random audits on original patient records, laboratory reports or other raw data sources and underlying data recorded on the CRFs (such audits to be performed in accordance with the terms of this Agreement); f. Submit all Protocol-required data and information to the Sponsor, IRB/EC and all regulatory authorities, as applicable and undertake all Protocol-required activities, so that the time schedules set forth in the Protocol and this Agreement are strictly met; g. Record all adverse events on the Adverse Events page(s) of the CRF in accordance with the Protocol. In the event of serious adverse events (“SAEs”), as defined in the Protocol and applicable regulations, Institution shall promptly and fully comply with all the notification procedures, time frames and requirements stated in the Protocol. If the Protocol does not identify the party(s) that is to be notified of SAEs, then the Institution shall promptly notify Sponsor, by both telephone and telefax, of all SAEs within 24 hours of becoming aware of the occurrence. In the event of SAEs that are immediately life-threatening or that result in death, the Institution shall immediately notify the party(s) specified in the Protocol by both telephone and telefax, and if the Protocol does not identify the parties who are to be notified of SAEs, the Institution shall immediately notify the Sponsor by both telephone and telefax. Investigator will promptly notify Sponsor and/or their respective designee, of any other safety information, that is not a serious adverse event, and information regarding drug experience associated with the Study or the Study Drug as specified in the Protocol; h. Maintain records of patient identification, clinical observations, laboratory tests, and drug receipt and disposition as specified in the Protocol. Institution shall maintain all such records for the Study until the later of: (i) such period required by federal, state, national and local laws and regulations; (ii) two (2) years following the date a New Drug Application is approved for the Study Drug that is the subject of the Study; or (iii) two (2) years after the Investigational New Drug Application for such Study Drug is terminated or withdrawn. During the time periods stated in (i) – (iii) above, Institution shall not destroy any such records until it has obtained Sponsor’s prior written permission to do so. After such time period has elapsed, Institution shall be free to dispose of the records as it sees fit so long as it has provided Sponsor with sixty (60) days’ notice of disposal or destruction of records and an opportunity within such sixty (60) day period to take possession of such records; i. Cooperate with Sponsor and its agents (including, without limitation, its designated clinical research organization) in all of their efforts to monitor the Study, including but not limited to allowing direct access to records that are maintained as Electronic Medical Records or in Institution’s clinical files. Any such access will be upon reasonable advanced notice and at mutually agreeable times during Institution’s normal business hours; it being agreed that ten (10) business days is reasonable advance notice. The Institution reserves the right to restrict access to patient areas and may require Sponsor to meet certain standards required by applicable laws or Institution policy for access to records or patient care areas. The Sponsor will, and will cause its agents and representatives to, use and disclose any patient information in accordance with the patient’s informed consent form and applicable laws and regulations. No access to Institution’s financial records will be provided; j. Promptly notify Sponsor of any FDA regulatory inspections of which it becomes aware relating to the Study. If legally permissible and practicable, Sponsor shall be permitted to be present at any such inspections and shall have the opportunity to provide, review, and comment on any responses that may be required; k. Ensure that all clinical data is accurate, complete, and legible, and promptly and fully disclosed to and produced for the inspection and use of Sponsor or its agents in accordance with Section 2.0(i) above; and l. Supply to Sponsor or its agents written notice documenting continuing IRB/EC review. Institution and Principal Investigator will provide Sponsor or its designee with a copy of IRB’s approval of Institution’s, Principal Investigator’s and study personnel’s conduct of the Study at Institution and/or at Institution’s affiliated hospitals, including approval of the Protocol, the informed consent form to be executed by all Study subjects enrolled by Institution and Principal Investigator in the Study and the HIPAA authorization, including any amendments to the foregoing, together with all relevant correspondence with the IRB regarding such approval and/or the Study.
Appears in 1 contract
Samples: Clinical Trial Agreement (Synthetic Biologics, Inc.)
Conduct of Study. The Institution agrees, and Investigator acknowledges that each shall conduct the Study will be conducted in strict compliance with the Protocol, this Agreement and any amendments thereto, any and all applicable federal, state, and local laws, regulations, good clinical practices, all reasonable written instructions of the Sponsor or its designee (e.g. CRO) and any other relevant professional standards. Investigator shall also conduct the Study in accordance with applicable laws, rules, and regulations governing the conduct of clinical trials and pertaining to investigational drugs, generally accepted good clinical practice and the conditions specified in the Statement of Investigator, FDA Form 1572 (or Investigator Agreement for medical device studies), which Investigator has completed, signed, and delivered to Sponsor prior to the commencement of the Study at the Investigator’s site. Further, the Institution agrees, and Investigator acknowledges that in the performance of the Study, each shall:
(a) Exercise independent medical judgment as to the compatibility of each Study participant with Protocol requirements (applicable to Investigator only);
(b) Xxxxxx a signed informed consent form (in a form approved by Sponsor) from each Study participant or his/her legally authorized representative and his/her caregiver in accordance with the Protocol, which has been approved by the IRB and Sponsor in accordance with 21 CFR §56, et. seq., or any successor thereto;
(c) Properly perform and direct or administer the Study in accordance with the Protocol, the applicable laws and regulations, the guideline published by the U.S. Food and Drug Administration (“FDA”) Form 1572entitled, “Good Clinical Practices, Consolidated Guideline” as described in 21 Code of Federal Regulations (“CFR”) 312.53, which Institution and Principal Investigator shall have signed and Institution shall have returned amended from time to Sponsor prior to the commencement of the Study. Institution acknowledges and agrees that it is responsible for (A) the actions, performancetime, and conduct of the Principal Investigator, and (B) Principal Investigator’s compliance with all of Principal Investigator’s obligations other requirements as set forth in this Agreement. Any failure by the Principal Investigator to perform or satisfy an obligation herein shall be considered a breach of this Agreement by Institution. Institution agrees to use its reasonable efforts to ensure that the Principal Investigator complies fully with the terms of the Protocol. In the performance of the Study the Institution specifically represents that it shalltherein, and shall require the Principal Investigator and all employees engaged in the performance of the Study to:
a. Exercise independent including ISO 14155:2020 for medical judgment as to the compatibility of each patient with Protocol requirements;
b. Obtain from each patient in the Study and before the Study subject begins participating in the Study a signed informed consent form in a form which has been approved by the IRB/EC and reviewed and approved by Sponsor in accordance with the Protocol and with 21 CFR Part 50 and/or the International Conference on Harmonisation Guidelines for Good Clinical Practice as adopted by the FDA (“ICH GCPs”)device studies, as applicable Institution will allow Sponsor and/or their respective designees to inspect signed informed consent forms or make photocopies thereof during monitoring visits or audits conducted in accordance with the terms of this Agreement ;
c. Properly perform and direct the Study in accordance with applicable laws, the Protocol and ICH GCPs and FDA GCPs;
d. Ensure that all advertising, recruitment, and training materials developed by Institution, Principal Investigator, or any of Institution’s employees, affiliates or agents in connection with the Study will comply with the Protocol, as well as all applicable laws, regulations, codes and rules, and receive prior review and approval by Sponsor and the IRB/EC, as if applicable;
e. (d) Review all patient Study participant case report forms (hereinafter “CRFs”) to assure their accuracy and completeness, and assist Sponsor’s representatives and clinical monitors upon request in promptly resolving any discrepancies or errors on CRFs and in performing random audits on of original patient records, laboratory reports reports, or other raw data sources and underlying data recorded on the CRFs (such audits to be performed in accordance with the terms of this Agreement)CRFs;
f. (e) Submit all Protocol-required data and information to the Sponsorinformation, IRB/EC and all regulatory authorities, as applicable and undertake all Protocol-required activities, so that the time schedules timeline as defined in the schedule of assessments set forth in the Protocol and this Agreement are strictly met;
g. Record all adverse events on (f) Notify Sponsor and the Adverse Events page(s) IRB promptly of the CRF in accordance with the Protocol. In the event of serious adverse events (“SAEs”), as defined in the Protocol and applicable regulations, Institution shall promptly and fully any failures to comply with all the notification procedures, time frames and requirements stated in the Protocol. If the Protocol does not identify the party(s) that is to be notified of SAEs, then the Institution shall promptly notify Sponsor, by both telephone and telefax, of all SAEs within 24 hours of becoming aware of the occurrence. In the event of SAEs that are immediately life-threatening or that result in death, the Institution shall immediately notify the party(s) specified in the Protocol by both telephone and telefax, and if the Protocol does not identify the parties who are to be notified of SAEs, the Institution shall immediately notify the Sponsor by both telephone and telefax. Investigator will promptly notify Sponsor and/or their respective designee, of any other safety information, that is not a serious adverse event, and information regarding drug experience associated with the Study or the Study Drug as specified in the Protocol;
h. (g) Maintain records of patient Study participant identification, clinical observations, laboratory tests, and drug receipt receipt, storage, return and disposition as specified in the Protocol. Institution shall maintain all such records for the Study until the later of: (i) such period required by federal, state, national and local laws and regulations; (ii) two (2) years following the date a New Drug Application is approved for the Study Drug that is the subject of the Study; or (iii) two (2) years after the Investigational New Drug Application for such Study Drug is terminated or withdrawn. During the time periods stated in (i) – (iii) above, Institution shall not destroy any such records until it has obtained Sponsor’s prior written permission to do so. After such time period has elapsed, Institution shall be free to dispose of the records as it sees fit so long as it has provided Sponsor with sixty (60) days’ notice of disposal or destruction of records and an opportunity within such sixty (60) day period to take possession of such records;
i. Cooperate (h) Provide all reasonable cooperation with Sponsor and its agents (including, without limitation, its designated clinical research organization) designee in all of their efforts to monitor the Study;
(i) Pursuant to 21 CFR §312.66, including but not limited to allowing direct access to records assure that are maintained as Electronic Medical Records or in Institution’s clinical files. Any such access the IRB will be upon reasonable advanced notice and at mutually agreeable times during Institution’s normal business hours; it being agreed that ten (10) business days is reasonable advance notice. The Institution reserves the right to restrict access to patient areas and may require Sponsor to meet certain standards required by applicable laws or Institution policy for access to records or patient care areas. The Sponsor will, and will cause its agents and representatives to, use and disclose any patient information in accordance comply with the patient’s informed consent form requirements of 21 CFR §56, et. Seq.;
(j) Perform the services in relation to the Study with reasonable care, diligence and skill and ensure that personnel engaged by it in the provision of such Study services are competent and have appropriate professional qualifications, training and experience (Only applicable laws and regulations. No access to Institution’s financial records will be provided;
j. Promptly notify Sponsor of any FDA regulatory inspections of which it becomes aware relating to the Study. If legally permissible and practicable, Sponsor shall be permitted to be present at any such inspections and shall have the opportunity to provide, review, and comment on any responses that may be required;
k. Ensure that all clinical data is accurate, complete, and legible, and promptly and fully disclosed to and produced for the inspection and use of Sponsor or its agents in accordance with Section 2.0(i) above); and
l. Supply to Sponsor or its agents written notice documenting continuing IRB/EC review. Institution and Principal (k) Upon request from Xxxxxxx, Investigator will provide Sponsor or its designee with update his/her financial disclosure form in a copy of IRB’s approval of timely matter one (1) year after Study completion. < Institution’s, Principal Investigator’s and study personnel’s conduct of the Study at Institution and/or at Institution’s affiliated hospitals, including approval of the Protocol, the informed consent form to be executed by all Study subjects enrolled by Institution and Principal Investigator in the Study and the HIPAA authorization, including any amendments to the foregoing, together with all relevant correspondence with the IRB regarding such approval and/or the Study.> CTA
Appears in 1 contract
Samples: Clinical Trial Agreement (60 Degrees Pharmaceuticals, Inc.)
Conduct of Study. The Institution agree to conduct the Study will be conducted in strict compliance with the Protocol, this Agreement and any amendments thereto, any and all applicable federal, state, and local laws, regulations, good clinical practices as adopted by current FDA regulations and statutes and regulations of the U.S., all reasonable written instructions of the Sponsor or its designee (e.g. CRO) and any other applicable professional standards. Institution also agrees specifically to conduct the Study in accordance with applicable laws, rules, and regulations governing the conduct of clinical trials and pertaining to investigational drugs, generally accepted good clinical practice and the conditions specified in the Statement of Investigator, FDA Form 1572, which Investigator has completed, signed, and delivered to Sponsor prior to the commencement of the Study at Institution. The Institution further agrees that in the performance of the Study, it shall:
(a) Require the Investigator to exercise independent medical judgment as to the compatibility of each Study participant with Protocol requirements;
(b) Xxxxxx a signed informed consent form (in a form approved by Sponsor) from each Study participant or his/her legally authorized representative and his/her caregiver in accordance with the Protocol, which has been approved by the IRB and Sponsor in accordance with 21 CFR §56, et. seq., or any successor thereto;
(c) Properly perform and direct or administer the Study in accordance with the Protocol, the applicable laws and regulations, the guideline published by the U.S. Food and Drug Administration (“FDA”) Form 1572entitled, “Good Clinical Practices, Consolidated Guideline” as described in 21 Code of Federal Regulations (“CFR”) 312.53, which Institution and Principal Investigator shall have signed and Institution shall have returned amended from time to Sponsor prior to the commencement of the Study. Institution acknowledges and agrees that it is responsible for (A) the actions, performancetime, and conduct of the Principal Investigator, and (B) Principal Investigator’s compliance with all of Principal Investigator’s obligations other requirements as set forth in this Agreement. Any failure by the Principal Investigator to perform or satisfy an obligation herein shall be considered a breach of this Agreement by Institution. Institution agrees to use its reasonable efforts to ensure that the Principal Investigator complies fully with the terms of the Protocol. In the performance of the Study the Institution specifically represents that it shall, and shall require the Principal Investigator and all employees engaged in the performance of the Study to:
a. Exercise independent medical judgment as to the compatibility of each patient with Protocol requirementstherein;
b. Obtain from each patient in the Study and before the Study subject begins participating in the Study a signed informed consent form in a form which has been approved by the IRB/EC and reviewed and approved by Sponsor in accordance with the Protocol and with 21 CFR Part 50 and/or the International Conference on Harmonisation Guidelines for Good Clinical Practice as adopted by the FDA (“ICH GCPs”), as applicable Institution will allow Sponsor and/or their respective designees to inspect signed informed consent forms or make photocopies thereof during monitoring visits or audits conducted in accordance with the terms of this Agreement ;
c. Properly perform and direct the Study in accordance with applicable laws, the Protocol and ICH GCPs and FDA GCPs;
d. Ensure that all advertising, recruitment, and training materials developed by Institution, Principal Investigator, or any of Institution’s employees, affiliates or agents in connection with the Study will comply with the Protocol, as well as all applicable laws, regulations, codes and rules, and receive prior review and approval by Sponsor and the IRB/EC, as applicable;
e. d) Review all patient Study participant case report forms (hereinafter “CRFs”) to assure their accuracy and completeness, and assist Sponsor’s representatives and clinical monitors upon request in promptly resolving any discrepancies or errors on CRFs and in performing random audits on of original patient records, laboratory reports reports, or other raw data sources and underlying data recorded on the CRFs (such audits to be performed in accordance with the terms of this Agreement)CRFs;
f. (e) Submit all Protocol-required data and information to the Sponsorinformation, IRB/EC and all regulatory authorities, as applicable and undertake all Protocol-required activities, so that the time schedules timeline as defined in the schedule of assessments set forth in the Protocol and this Agreement are strictly met;
g. Record all adverse events on (f) Notify Sponsor and the Adverse Events page(s) of the CRF in accordance with the Protocol. In the event of serious adverse events (“SAEs”), as defined in the Protocol and applicable regulations, Institution shall promptly and fully comply with all the notification procedures, time frames and requirements stated in the Protocol. If the Protocol does not identify the party(s) that is to be notified of SAEs, then the Institution shall promptly notify Sponsor, by both telephone and telefax, of all SAEs within 24 hours of IRB immediately upon becoming aware of the occurrence. In the event of SAEs that are immediately life-threatening or that result in death, the Institution shall immediately notify the party(s) specified in the Protocol by both telephone and telefax, and if the Protocol does not identify the parties who are any failures to be notified of SAEs, the Institution shall immediately notify the Sponsor by both telephone and telefax. Investigator will promptly notify Sponsor and/or their respective designee, of any other safety information, that is not a serious adverse event, and information regarding drug experience associated comply with the Study or the Study Drug as specified in the Protocol;
h. (g) Maintain records of patient Study participant identification, clinical observations, laboratory tests, and drug receipt receipt, storage, return and disposition as specified in the Protocol. Institution shall maintain all such records for the Study until the later of: (i) such period required by federal, state, national and local laws and regulations; (ii) two (2) years following the date a New Drug Application is approved for the Study Drug that is the subject of the Study; or (iii) two (2) years after the Investigational New Drug Application for such Study Drug is terminated or withdrawn. During the time periods stated in (i) – (iii) above, Institution shall not destroy any such records until it has obtained Sponsor’s prior written permission to do so. After such time period has elapsed, Institution shall be free to dispose of the records as it sees fit so long as it has provided Sponsor with sixty (60) days’ notice of disposal or destruction of records and an opportunity within such sixty (60) day period to take possession of such records;
i. Cooperate (h) Provide all reasonable cooperation with Sponsor and its agents (including, without limitation, its designated clinical research organization) designee in all of their efforts to monitor the Study;
(i) Pursuant to 21 CFR §312.66, including but not limited to allowing direct access to records assure that are maintained as Electronic Medical Records or in Institution’s clinical files. Any such access the IRB will be upon reasonable advanced notice and at mutually agreeable times during Institution’s normal business hours; it being agreed that ten (10) business days is reasonable advance notice. The Institution reserves the right to restrict access to patient areas and may require Sponsor to meet certain standards required by applicable laws or Institution policy for access to records or patient care areas. The Sponsor will, and will cause its agents and representatives to, use and disclose any patient information in accordance comply with the patient’s informed consent form and applicable laws and regulationsrequirements of 21 CFR §56, et. No access to Institution’s financial records will be providedSeq.;
j. Promptly notify Sponsor of any FDA regulatory inspections of which it becomes aware relating (j) Perform the services in relation to the Study. If legally permissible Study with reasonable care, diligence and practicableskill and ensure that personnel engaged by it in the provision of such Study services are competent and have appropriate professional qualifications, Sponsor shall be permitted to be present at any such inspections training and shall have the opportunity to provide, review, and comment on any responses that may be required;
k. Ensure that all clinical data is accurate, complete, and legible, and promptly and fully disclosed to and produced for the inspection and use of Sponsor or its agents in accordance with Section 2.0(i) aboveexperience; and
l. Supply to Sponsor or its agents written notice documenting continuing IRB/EC review. Institution and Principal (k) Upon request from Xxxxxxx, Investigator will provide Sponsor or its designee with update his/her financial disclosure form in a copy of IRB’s approval of Institution’s, Principal Investigator’s and study personnel’s conduct of the timely matter one (1) year after Study at Institution and/or at Institution’s affiliated hospitals, including approval of the Protocol, the informed consent form to be executed by all Study subjects enrolled by Institution and Principal Investigator in the Study and the HIPAA authorization, including any amendments to the foregoing, together with all relevant correspondence with the IRB regarding such approval and/or the Studycompletion.
Appears in 1 contract
Samples: Clinical Trial Agreement (60 Degrees Pharmaceuticals, Inc.)
Conduct of Study. The Study will be conducted in accordance with applicable laws, rules, and regulations governing the conduct of clinical trials and pertaining to investigational drugs, generally accepted good clinical practice and the conditions specified in the Statement of Investigator, U.S. Food and Drug Administration (“FDA”a) Form 1572, as described in 21 Code of Federal Regulations (“CFR”) 312.53, which Institution and Principal Investigator shall have signed and Institution shall have returned to Sponsor prior to the commencement of the Study. Institution acknowledges conduct and agrees that it is responsible for (A) the actions, performance, and conduct of the shall require Principal Investigator, subinvestigator(s), and Institution’s other employees, subcontractors and agents performing work in connection with the Study (collectively, “Institution Personnel”) to conduct the Study in accordance with: (i) this Agreement and the relevant Statement of Work; (ii) the IRB-approved Protocol; (iii) all reasonable written instruction provided by or on behalf of Pharmacyclics; (iv) Institution’s ethical standards and/or policies; and (Bv) Principal Investigator’s compliance with all of Principal Investigator’s obligations set forth in this Agreement. Any failure by the Principal Investigator to perform or satisfy an obligation herein shall be considered a breach of this Agreement by Institution. Institution agrees to use its reasonable efforts to ensure that the Principal Investigator complies fully with the terms of the Protocol. In the performance of the Study the Institution specifically represents that it shallapplicable federal, state and shall require the Principal Investigator local laws and all employees engaged in the performance of the Study to:
a. Exercise independent medical judgment as regulations and guidelines (collectively, “Law(s)”), including without limitation (and each to the compatibility extent applicable to a Study), anti-bribery and anti-corruption laws, International Council for Harmonisation of each patient with Protocol requirements;
b. Obtain from each patient in the Study and before the Study subject begins participating in the Study a signed informed consent form in a form which has been approved by the IRB/EC and reviewed and approved by Sponsor in accordance with the Protocol and with 21 CFR Part 50 and/or the International Conference on Harmonisation Guidelines Technical Requirements for Registration of Pharmaceuticals for Human Use E6 Good Clinical Practice as adopted by the FDA (“ICH GCPsICH-GCP”), regulations of the United States Food and Drug Administration (the “FDA”), the Patient Protection and Affordable Care Act of 2010, the Medicare/Medicaid Anti- kickback statute, the Social Security Act of 1935, the Controlled Substances Act, data protection and privacy laws, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and the Federal Food, Drug and Cosmetic Act of 1938, as each may be amended, from time to time. In furtherance of the foregoing obligations, Institution shall ensure that an Institution Review Board (“IRB”) established and constituted in accordance with applicable Laws approves and oversees the conduct of the Study prior to the commencement of the Study. Institution will comply with the instructions of the IRB respecting the conduct of the Study, and will notify Pharmacyclics to the extent any such instructions vary from the Protocol.
(b) Prior to each Study subject’s participation in the Study, Institution shall obtain a signed informed consent and/or authorization document (collectively, “ICF”), as reviewed by Pharmacyclics and approved by the IRB. If Institution or Principal Investigator proposes to publish any Study subject recruitment advertisements, such advertisements require Pharmacyclics’ prior review in advance of submission to the applicable IRB. Institution will allow Sponsor and/or their respective designees to inspect signed informed consent forms and Principal Investigator shall report all serious adverse events or make photocopies thereof during monitoring visits or audits conducted in accordance with other safety concerns arising from the terms conduct of this Agreement ;
c. Properly perform and direct the Study that Principal Investigator becomes aware of as further specified in the Protocol and in accordance with applicable laws, the Protocol Laws.
(c) Institution represents and ICH GCPs and FDA GCPs;
d. Ensure certifies that all advertising, recruitment, and training materials developed by Institution, Principal Investigator, or any Investigator identified in a Statement of Work is an employee of Institution’s employees, affiliates . Institution agrees that no other investigator may be substituted for the Principal Investigator without the prior written consent of Pharmacyclics. If the Principal Investigator is no longer employed by Institution or agents in connection with becomes unwilling or unable to perform the Study will comply with the Protocol, as well as all applicable laws, regulations, codes and rules, and receive prior review and approval duties required by Sponsor and the IRB/EC, as applicable;
e. Review all patient case report forms (hereinafter “CRFs”) to assure their accuracy and completeness, and assist Sponsor’s representatives and clinical monitors upon request in promptly resolving any discrepancies or errors on CRFs and in performing random audits on original patient records, laboratory reports or other raw data sources and underlying data recorded on the CRFs (such audits to be performed in accordance with the terms of this Agreement);
f. Submit all Protocol-required data and information to the Sponsor, IRB/EC and all regulatory authorities, as applicable and undertake all Protocol-required activities, so that the time schedules set forth in the Protocol and this Agreement are strictly met;
g. Record all adverse events on the Adverse Events page(s) and relevant Statement of the CRF in accordance with the Protocol. In the event of serious adverse events (“SAEs”), as defined in the Protocol and applicable regulationsWork, Institution shall promptly notify Pharmacyclics and fully comply reasonably cooperate with all the notification procedures, time frames and requirements stated in the ProtocolPharmacyclics to promptly find a mutually acceptable replacement Principal Investigator. If the Protocol does parties cannot identify agree to a replacement Principal Investigator, either party may immediately terminate the party(srelevant Statement of Work upon written notice to the other party.
(d) that is to be notified of SAEs, then the Institution shall promptly notify Sponsor, by both telephone ensure that Principal Investigator and telefax, of all SAEs within 24 hours of becoming aware of the occurrence. In the event of SAEs that are immediately life-threatening or that result in death, the Institution shall immediately notify the party(s) specified in the Protocol by both telephone and telefax, and if the Protocol does not identify the parties who are to be notified of SAEs, the Institution shall immediately notify the Sponsor by both telephone and telefax. Investigator will promptly notify Sponsor and/or their respective designee, of any other safety information, that is not a serious adverse event, and information regarding drug experience associated with the Study or the Study Drug as specified in the Protocol;
h. Maintain records of patient identification, clinical observations, laboratory tests, and drug receipt and disposition as specified in the Protocol. Institution shall maintain all such records for the Study until the later of: subinvestigator(s): (i) such period required complete and return to Pharmacyclics the FDA Form 1572 provided by federal, state, national Pharmacyclics to ensure compliance with 21 C.F.R. Part 312.53 prior to the initiation of the Study and local laws promptly notify Pharmacyclics of any change in its accuracy during the Study Term of the applicable Statement of Work; and regulations; (ii) two (2) years following complete and return to Pharmacyclics the date a New Drug Application is approved for Financial Disclosure Certification provided by Pharmacyclics to ensure compliance with 21C.F.R. Part 54 prior to the initiation of the Study Drug that is and promptly notify Pharmacyclics of any change in the subject accuracy of the Financial Disclosure Certification during the Study Term of the applicable Statement of Work and for one (1) year following completion of the Study; or (iii) two (2) years after the Investigational New Drug Application for such Study Drug is terminated or withdrawn. During the time periods stated Institution understands and agrees that Principal Investigator and subinvestigator(s), and their immediate families, may not, in (i) – (iii) aboveviolation of any applicable Law, Institution shall not destroy any such records until it has obtained Sponsor’s prior written permission to do so. After such time period has elapsed, Institution shall be free to dispose of the records as it sees fit so long as it has provided Sponsor with sixty (60) days’ notice of disposal or destruction of records and an opportunity within such sixty (60) day period to take possession of such records;
i. Cooperate with Sponsor and its agents have a direct ownership interest (including, without limitation, its designated clinical research organizationintellectual property rights or royalty rights) in all of their efforts to monitor the Study Product and may not be compensated with Pharmacyclics’ and/or its Affiliates’ securities in exchange for being a Principal Investigator or subinvestigator(s) in the Study.
(e) Institution shall require Principal Investigator to comply with all applicable disclosure Laws relating to his/her relationship with Pharmacyclics, and its Affiliates and/or collaborators, including, without limitation, full disclosure of the existence and nature of this relationship that (i) may be externally imposed on Principal Investigator based on his/her affiliation with any formulary, pharmacy and therapeutics (P&T) committee, or committee associated with the development of treatment protocols or standards (including but clinical guidelines); or (ii) are required by any health care institution, medical committee or other medical or scientific organization with which Principal Investigator is affiliated. Institution shall require Principal Investigator to abide by such committee’s or medical or scientific organization’s procedures, which may include recusing himself/herself from decisions relating to any Study Product for which Principal Investigator is conducting the Study under the relevant Statement of Work. This disclosure requirement shall extend for one (1) year beyond the termination or expiration of the relevant Statement of Work.
(f) Institution and Institution Personnel shall not limited to allowing direct access to records xxxx or seek reimbursement from any third party for any Study Materials (as defined below in Section 5(a)) or other items or services that are maintained as Electronic Medical Records paid for or provided without charge by or on behalf of Pharmacyclics under this Agreement. Institution shall follow all applicable Laws requiring disclosure that such Study Materials and/or other items, or services were paid for or provided without charge by or on behalf of Pharmacyclics under this Agreement.
(g) All completed CRFs (defined below in Institution’s clinical files. Any such access will Section 6(a)) must be upon reasonable advanced notice and at mutually agreeable times during Institution’s normal business hours; it being agreed that entered in the electronic data capture system within ten (10) business days is reasonable advance notice. The Institution reserves of each visit and within ten (10) business days of each follow-up visit; and within ten (10) business days of the right to restrict access to patient areas and may require Sponsor to meet certain standards required by applicable laws or Institution policy for access to records or patient care areas. The Sponsor will, and will cause its agents and representatives to, use and disclose any patient information in accordance with the patient’s informed consent form and applicable laws and regulations. No access to Institution’s financial records will be provided;
j. Promptly notify Sponsor of any FDA regulatory inspections of which it becomes aware relating to the Study. If legally permissible and practicable, Sponsor shall be permitted to be present at any such inspections and shall have the opportunity to provide, review, and comment on any responses that may be required;
k. Ensure that all clinical data is accurate, complete, and legible, and promptly and fully disclosed to and produced for the inspection and use of Sponsor or its agents in accordance with Section 2.0(i) above; and
l. Supply to Sponsor or its agents written notice documenting continuing IRB/EC review. Institution and Principal Investigator will provide Sponsor or its designee with a copy of IRB’s approval of Institution’s, Principal Investigator’s and study personnel’s conduct completion of the Study at subject's participation in a Study and receipt of Study subject's test results, if any, but in no event later than the Study completion date. Any requests by or on behalf of Pharmacyclics to Institution and/or at for verification, clarification or correction of data on CRFs must be responded to within ten (10) business days of Institution’s affiliated hospitals, including approval receipt of the Protocol, the informed consent form to be executed by all Study subjects enrolled by Institution and Principal Investigator in the Study and the HIPAA authorization, including any amendments to the foregoing, together with all relevant correspondence with the IRB regarding such approval and/or the Studyrequest.
Appears in 1 contract
Samples: Master Clinical Study Agreement
Conduct of Study. The Study will be conducted in accordance with applicable laws, rules, and regulations governing the conduct of clinical trials and pertaining to investigational drugs, generally accepted good clinical practice and the conditions specified in the Statement of Investigator, U.S. Food and Drug Administration (“FDA”a) Form 1572, as described in 21 Code of Federal Regulations (“CFR”) 312.53, which Institution and Principal Investigator shall have signed and Institution shall have returned to Sponsor prior to the commencement of the Study. Institution acknowledges conduct and agrees that it is responsible for (A) the actions, performance, and conduct of the shall require Principal Investigator, subinvestigator(s), and Institution’s other employees, subcontractors and agents performing work in connection with the Study (collectively, “Institution Personnel”) to conduct the Study in accordance with: (i) this Agreement and the relevant Statement of Work; (ii) the IRB-approved Protocol; (iii) all reasonable written instruction provided by AbbVie; (iv) Institution’s ethical standards and/or policies; and (Bv) Principal Investigator’s compliance with all of Principal Investigator’s obligations set forth in this Agreement. Any failure by the Principal Investigator to perform or satisfy an obligation herein shall be considered a breach of this Agreement by Institution. Institution agrees to use its reasonable efforts to ensure that the Principal Investigator complies fully with the terms of the Protocol. In the performance of the Study the Institution specifically represents that it shallapplicable federal, state and shall require the Principal Investigator local laws and all employees engaged in the performance of the Study to:
a. Exercise independent medical judgment as regulations and guidelines (collectively, “Law(s)”), including without limitation (and each to the compatibility of each patient with Protocol requirements;
b. Obtain from each patient in the Study extent applicable to a Study), anti-bribery and before the Study subject begins participating in the Study a signed informed consent form in a form which has been approved by the IRB/EC and reviewed and approved by Sponsor in accordance with the Protocol and with 21 CFR Part 50 and/or the anti- corruption laws, International Conference on Harmonisation Guidelines of Technical Requirements for Registration of Pharmaceuticals for Human Use E6 Good Clinical Practice as adopted by the FDA (“ICH GCPsICH-GCP”), regulations of the United States Food and Drug Administration (the “FDA”), the Patient Protection and Affordable Care Act of 2010, the Medicare/Medicaid Anti-kickback statute, the Social Security Act of 1935, the Controlled Substances Act, data protection and privacy laws, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and the Federal Food, Drug and Cosmetic Act of 1938, as each may be amended, from time to time. In furtherance of the foregoing obligations, Institution shall ensure that an Institution Review Board (“IRB”) established and constituted in accordance with applicable Laws approves and oversees the conduct of the Study prior to the commencement of the Study. Institution will comply with the instructions of the IRB respecting the conduct of the Study, and will notify AbbVie to the extent any such instructions vary from the Protocol.
(b) Prior to each Study subject’s participation in the Study, Institution shall obtain a signed informed consent and/or authorization document (collectively, “ICF”), as reviewed by AbbVie and approved by the IRB. If Institution or Principal Investigator proposes to publish any Study subject recruitment advertisements, such advertisements require AbbVie’s prior review in advance of submission to the applicable IRB. Institution will allow Sponsor and/or their respective designees to inspect signed informed consent forms and Principal Investigator shall report all serious adverse events or make photocopies thereof during monitoring visits or audits conducted in accordance with other safety concerns arising from the terms conduct of this Agreement ;
c. Properly perform and direct the Study that Principal Investigator becomes aware of as further specified in the Protocol and in accordance with applicable laws, the Protocol Laws.
(c) Institution represents and ICH GCPs and FDA GCPs;
d. Ensure certifies that all advertising, recruitment, and training materials developed by Institution, Principal Investigator, or any Investigator identified in a Statement of Work is an employee of Institution’s employees, affiliates . Institution agrees that no other investigator may be substituted for the Principal Investigator without the prior written consent of AbbVie. If the Principal Investigator is no longer employed by Institution or agents in connection with becomes unwilling or unable to perform the Study will comply with the Protocol, as well as all applicable laws, regulations, codes and rules, and receive prior review and approval duties required by Sponsor and the IRB/EC, as applicable;
e. Review all patient case report forms (hereinafter “CRFs”) to assure their accuracy and completeness, and assist Sponsor’s representatives and clinical monitors upon request in promptly resolving any discrepancies or errors on CRFs and in performing random audits on original patient records, laboratory reports or other raw data sources and underlying data recorded on the CRFs (such audits to be performed in accordance with the terms of this Agreement);
f. Submit all Protocol-required data and information to the Sponsor, IRB/EC and all regulatory authorities, as applicable and undertake all Protocol-required activities, so that the time schedules set forth in the Protocol and this Agreement are strictly met;
g. Record all adverse events on the Adverse Events page(s) and relevant Statement of the CRF in accordance with the Protocol. In the event of serious adverse events (“SAEs”), as defined in the Protocol and applicable regulationsWork, Institution shall promptly notify AbbVie and fully comply reasonably cooperate with all the notification procedures, time frames and requirements stated in the ProtocolAbbVie to promptly find a mutually acceptable replacement Principal Investigator. If the Protocol does parties cannot identify agree to a replacement Principal Investigator, either party may immediately terminate the party(srelevant Statement of Work upon written notice to the other party.
(d) that is to be notified of SAEs, then the Institution shall promptly notify Sponsor, by both telephone ensure that Principal Investigator and telefax, of all SAEs within 24 hours of becoming aware of the occurrence. In the event of SAEs that are immediately life-threatening or that result in death, the Institution shall immediately notify the party(s) specified in the Protocol by both telephone and telefax, and if the Protocol does not identify the parties who are to be notified of SAEs, the Institution shall immediately notify the Sponsor by both telephone and telefax. Investigator will promptly notify Sponsor and/or their respective designee, of any other safety information, that is not a serious adverse event, and information regarding drug experience associated with the Study or the Study Drug as specified in the Protocol;
h. Maintain records of patient identification, clinical observations, laboratory tests, and drug receipt and disposition as specified in the Protocol. Institution shall maintain all such records for the Study until the later of: subinvestigator(s): (i) such period required complete and return to AbbVie the FDA Form 1572 provided by federal, state, national AbbVie to ensure compliance with 21 C.F.R. Part 312.53 prior to the initiation of the Study and local laws promptly notify AbbVie of any change in its accuracy during the Study Term of the applicable Statement of Work; and regulations; (ii) two (2) years following complete and return to AbbVie the date a New Drug Application is approved for Financial Disclosure Certification provided by AbbVie to ensure compliance with 21C.F.R. Part 54 prior to the initiation of the Study Drug that is and promptly notify AbbVie of any change in the subject accuracy of the Financial Disclosure Certification during the Study Term of the applicable Statement of Work and for one (1) year following completion of the Study; or (iii) two (2) years after the Investigational New Drug Application for such Study Drug is terminated or withdrawn. During the time periods stated Institution understands and agrees that Principal Investigator and subinvestigator(s), and their immediate families, may not, in (i) – (iii) aboveviolation of any applicable Law, Institution shall not destroy any such records until it has obtained Sponsor’s prior written permission to do so. After such time period has elapsed, Institution shall be free to dispose of the records as it sees fit so long as it has provided Sponsor with sixty (60) days’ notice of disposal or destruction of records and an opportunity within such sixty (60) day period to take possession of such records;
i. Cooperate with Sponsor and its agents have a direct ownership interest (including, without limitation, its designated clinical research organizationintellectual property rights or royalty rights) in all of their efforts to monitor the Study, including but not limited to allowing direct access to records that are maintained as Electronic Medical Records or in Institution’s clinical files. Any such access will be upon reasonable advanced notice and at mutually agreeable times during Institution’s normal business hours; it being agreed that ten (10) business days is reasonable advance notice. The Institution reserves the right to restrict access to patient areas and may require Sponsor to meet certain standards required by applicable laws or Institution policy for access to records or patient care areas. The Sponsor will, and will cause its agents and representatives to, use and disclose any patient information in accordance with the patient’s informed consent form and applicable laws and regulations. No access to Institution’s financial records will be provided;
j. Promptly notify Sponsor of any FDA regulatory inspections of which it becomes aware relating to the Study. If legally permissible and practicable, Sponsor shall be permitted to be present at any such inspections and shall have the opportunity to provide, review, and comment on any responses that may be required;
k. Ensure that all clinical data is accurate, complete, and legible, and promptly and fully disclosed to and produced for the inspection and use of Sponsor or its agents in accordance with Section 2.0(i) above; and
l. Supply to Sponsor or its agents written notice documenting continuing IRB/EC review. Institution and Principal Investigator will provide Sponsor or its designee with a copy of IRB’s approval of Institution’s, Principal Investigator’s and study personnel’s conduct of the Study at Institution and/or at Institution’s affiliated hospitals, including approval of the Protocol, the informed consent form to be executed by all Study subjects enrolled by Institution and Principal Investigator in the Study Product and the HIPAA authorization, including any amendments to the foregoing, together may not be compensated with all relevant correspondence with the IRB regarding such approval and/or AbbVie securities in exchange for being a Principal Investigator or subinvestigator(s) in the Study.
(e) Institution shall require Principal Investigator to comply with all applicable disclosure Laws relating to his/her relationship with AbbVie including, without limitation, full disclosure of the existence and nature of this relationship that (i) may be externally imposed on Principal Investigator based on his/her affiliation with any formulary, pharmacy and therapeutics (P&T) committee, or committee associated with the development of treatment protocols or standards (including clinical guidelines); or (ii) are required by any health care institution, medical committee or other medical or scientific organization with which Principal Investigator is affiliated. Institution shall require Principal Investigator to abide by such committee’s or medical or scientific organization’s procedures, which may include recusing himself/herself from decisions relating to any Study Product for which Principal Investigator is conducting the Study under the relevant Statement of Work. This disclosure requirement shall extend for one (1) year beyond the termination or expiration of the relevant Statement of Work.
(f) Institution and Institution Personnel shall not bill or seek reimbursement from any third party for any Study Materials (as defined below) or other items or services that are paid for or provided without charge by or on behalf of AbbVie under this Agreement. Institution shall follow all applicable Law requiring disclosure that such Study Materials and/or other items, or services were paid for or provided without charge by or on behalf of AbbVie under this Agreement.
Appears in 1 contract
Samples: Master Clinical Study Agreement
