Common use of Study Documentation Clause in Contracts

Study Documentation. For each Study, the Institution and the Principal Investigator shall prepare, maintain and retain complete, current, accurate, organized and legible Study Documentation (as defined below) in a manner acceptable for the collection of data for submission to, or review by, the FDA and other regulatory or governmental authorities as applicable, and in full compliance with the applicable Protocol and all Applicable Laws. For purposes of this Agreement, “Study Documentation” includes all records related to the Study Device or Protocol, accounts, notes, reports and data, collected, generated or used in connection with the applicable Study, whether in written, electronic, video or other tangible form, including all recorded original observations and notations of clinical activities and all reports and records necessary for the evaluation and reconstruction of the Study. Study Documentation shall not include Subjects' medical records and other original source documents. The Principal Investigator and/or Institution will conduct data entry activities, which shall include entry of Subject data after Subject visit and response to queries, within the reasonable timelines provided by SPONSOR. For studies using web based electronic data capture technology (“EDC”), data will be entered in the EDC system at the Institution. Trained Study personnel will be responsible for entering data on the observations, tests and assessments specified in the Protocol into the EDC system and according to the CRF (as defined in Section 11.2). The CRF instructions will also provide the Institution with data entry instructions. Data entered in the EDC system will be automatically saved to a central database and changes tracked to provide an audit trail. When data have been entered, reviewed, edited, and Source Data Verification (“SDV”) performed, the Principal Investigator will be notified to sign the CRF electronically as per the agreed project process and data will be locked to prevent further editing. A copy of the CRF will be archived at the Institution at SPONSOR’s reasonable expense. When an electronic invalidated system that allows retrospective entry or correction of medical records data is issued, Principal Investigator shall print, sign, date and file a copy of the relevant medical record each time a Subject visits a facility at SPONSOR’s reasonable expense. The Principal Investigator’s electronic signature on such relevant medical record shall be the legally binding equivalent to a handwritten signature. If medical records of Subjects are held in a computerized medical record system, such system must be in full compliance with the applicable FDA rules on electronic records and signatures. In addition, and if applicable, Institution agrees to keep and maintain such records on the services provided as may be required by fiscal intermediaries, federal, state, or local governmental agencies, accreditation agencies, or other parties. Pursuant to Section 1395x (v) (1) (I) of Title 42 of the United States Code with respect to any services furnished under the terms of this Agreement, if the value or cost of which is Ten Thousand and No/100 Dollars ($10,000.00) or more over a twelve (12) month period, until the expiration of four (4) years after termination of this Agreement, both parties shall make available, upon written request to the Secretary of the United States Department of Health and Human Services, or upon request by the Comptroller General of the United States General Accounting Office, or any of their duly authorized representatives, a copy of this Agreement and such books, documents, and records as are necessary to certify the nature and extent of the costs of the services provided by Institution employee(s) under this Agreement.

Study Documentation. For each Study, the Institution and the Principal Investigator shall prepareensure that the preparation, maintain maintenance and retain retention of complete, current, accurate, organized and legible Study Documentation (as defined below) is performed in a manner acceptable for the collection of data for submission to, or review by, by the FDA and other regulatory or governmental authorities as applicable, and is in full compliance with the applicable Protocol and all Applicable Laws. For purposes of this Agreement, “Study Documentation” includes all records related to the Study Device or Protocol, accounts, notes, reports and data, collected, generated or used in connection with the applicable StudyStudy at the Institution, whether in written, electronic, video or other tangible form, including all recorded original observations and notations of clinical activities and all reports and records necessary for the evaluation and reconstruction of the StudyStudy as required by a Protocol and/or Applicable Laws. Study Documentation shall not include Subjects' medical records and other original source documentsdocuments or the information contained therein. The Principal Investigator and/or Institution will conduct data entry activities, which shall include entry of Subject data after Subject visit and response to queries, within the reasonable timelines provided by SPONSORSPONSOR in writing. For studies using web based electronic data capture technology (“EDC”), data will be entered in the EDC system at the Institution. Trained Study personnel Personnel will be responsible for entering data on the observations, tests and assessments specified in the Protocol into the EDC system and according to the CRF (as defined in Section 11.2). The CRF instructions will also provide the Institution with data entry instructions. Data entered in the EDC system will be automatically saved to a central database and changes tracked to provide an audit trail. When data have been entered, reviewed, edited, and Source Data Verification (“SDV”) performed, the Principal Investigator will be notified to sign the CRF electronically as per the agreed project process and data will be locked to prevent further editing. A copy of the CRF will be archived at the Institution at SPONSOR’s reasonable expense. When an electronic invalidated medical record system that allows retrospective entry or correction of medical records data is issuedused, Principal Investigator shall print, sign, date and file a copy of the relevant medical record each time a Subject visits a facility at SPONSOR’s reasonable expense. The Principal Investigator’s electronic signature on such relevant medical record shall be the legally binding equivalent to a handwritten signature. If medical records of Subjects are held in a computerized medical record system, such system must be in full compliance with the applicable FDA rules on electronic records and signatures. In addition, and if applicable, Institution agrees to keep and maintain such records on the services provided as may be required by fiscal intermediariesby, federal, state, or local governmental agencies, accreditation agencies, or other partiesparties with authority over the conduct of the Study. Pursuant to Section 1395x (v) (1) (I) of Title 42 of the United States Code with respect to any services furnished under the terms of this Agreement, if the value or cost of which is Ten Thousand and No/100 Dollars ($10,000.00) or more over a twelve (12) month period, until the expiration of four (4) years after termination of this Agreement, both parties shall make available, upon written request to the Secretary of the United States Department of Health and Human Services, or upon request by the Comptroller General of the United States General Accounting Office, or any of their duly authorized representatives, a copy of this Agreement and such books, documents, and records as are necessary to certify the nature and extent of the costs of the research services provided by Institution employee(s) under this Agreement.

Study Documentation. For each Study, the Institution and the Principal Investigator shall prepareensure that the preparation, maintain maintenance and retain retention of complete, current, accurate, organized and legible Study Documentation (as defined below) is performed in a manner acceptable for the collection of data for submission to, or review by, by the FDA and other regulatory or governmental authorities as applicable, and is in full compliance with the applicable Protocol and all Applicable Laws. For purposes of this Agreement, “Study Documentation” includes all records related to the Study Device or Protocol, accounts, notes, reports and data, collected, generated or used in connection with the applicable StudyStudy at the Institution, whether in written, electronic, video or other tangible form, including all recorded original observations and notations of clinical activities and all reports and records necessary for the evaluation and reconstruction of the StudyStudy as required by a Protocol and/or Applicable Laws. Study Documentation shall not include Subjects' medical records and other original source documentsdocuments or the information contained therein. The Principal Investigator and/or Institution will conduct data entry activities, which shall include entry of Subject data after Subject visit and response to queries, within the reasonable timelines provided by SPONSORSPONSOR in writing. For studies using web based electronic data capture technology (“EDC”), data will be entered in the EDC system at the Institution. Trained Study personnel Personnel will be responsible for entering data on the observations, tests and assessments specified in the Protocol into the EDC system and according to the CRF (as defined in Section 11.2). The CRF instructions will also provide the Institution with data entry instructions. Data entered in the EDC system will be automatically saved to a central database and changes tracked to provide an audit trail. When data have been entered, reviewed, edited, and Source Data Verification (“SDV”) performed, the Principal Investigator will be notified to sign the CRF electronically as per the agreed project process and data will be locked to prevent further editing. A copy of the CRF will be archived at the Institution at SPONSOR’s reasonable expense. When an electronic invalidated medical record system that allows retrospective entry or correction of medical records data is issuedused, Principal Investigator shall print, sign, date and file a copy of the relevant medical record each time a Subject visits a facility at SPONSOR’s reasonable expense. The Principal Investigator’s electronic signature on such relevant medical record shall be the legally binding equivalent to a handwritten signature. If medical records of Subjects are held in a computerized medical record system, such system must be in full compliance with the applicable FDA rules on electronic records and signatures. In addition, and if applicable, Institution agrees to keep and maintain such records on the services provided as may be required by fiscal intermediariesby, federal, state, or local governmental agencies, accreditation agencies, or other partiesparties with authority over the conduct of the Study. Pursuant to Section 1395x (v) (1) (I) of Title 42 of the United States Code with respect to any services furnished under the terms of this Agreement, if the value or cost of which is Ten Thousand and No/100 Dollars ($10,000.00) or more over a twelve (12) month period, until the expiration of four (4) years after termination of this Agreement, both parties shall make available, upon written request to the Secretary of the United States Department of Health and Human Services, or upon request by the Comptroller General of the United States General Accounting Office, or any of their duly authorized representatives, a copy of this Agreement and such books, documents, and records as are necessary to certify the nature and extent of the costs of the services provided by Institution employee(s) under this Agreement.four

Study Documentation. For each Study, the The Institution and the Principal Investigator shall prepare, maintain and retain complete, current, accurate, organized and legible Study Documentation (as defined below) in a manner acceptable for the collection of data for submission to, or review by, the FDA and other regulatory or governmental authorities as applicableauthorities, and in full compliance with the applicable Protocol and all Applicable Laws. [On a case-by-case basis, AstraZeneca may at its sole expense request, in writing, longer periods of retention times for Study Documentation.] For purposes of this Agreement, “Study Documentation” includes all records (related to the Study Device Drug or Protocol), accounts, notes, reports and data, collected, generated or used in connection with the applicable Study, whether in written, electronic, video or other tangible form, including all recorded original observations and notations of clinical activities and all reports and records necessary for the evaluation and reconstruction of the Study. Study Documentation shall not include Subjects' medical records and other original source documents. The Principal Investigator and/or Institution will conduct data entry activities, which shall include entry of Subject data after Subject visit and response to queries, within the reasonable timelines provided by SPONSORAstraZeneca. For studies using web based electronic data capture technology (“EDCWBDC”), data will be entered in the EDC WBDC system at the InstitutionStudy site. Trained Study personnel will be responsible for entering data on the observations, tests and assessments specified in the Protocol into the EDC WBDC system and according to the CRF (instructions as defined in Section 11.2)10.2. The CRF instructions will also provide the Institution Study site with data entry instructions. Data entered in the EDC WBDC system will be automatically saved to a central database and changes tracked to provide an audit trail. When data have been entered, reviewed, edited, and Source Data Verification (“SDV”) performed, the Principal Investigator will be notified to sign the CRF electronically as per the agreed project process and data will be locked to prevent further editing. A copy of the CRF will be archived at the Institution at SPONSOR’s reasonable expenseStudy site. When an electronic invalidated system that allows retrospective entry or correction of medical records data is issued, Principal Investigator shall print, sign, date and file a copy of the relevant medical record each time a Subject visits a facility at SPONSOR’s reasonable expenseattends the clinic. The Principal Investigator’s electronic signature on such relevant medical record shall be the legally binding equivalent to a handwritten signature. If medical records of Study Subjects are held in a computerized medical record system, such system must be in full compliance with the applicable FDA rules on electronic records and signatures. In addition, and if applicable, Institution agrees to keep and maintain such records on the services provided as may be required by fiscal intermediaries, federal, state, or local governmental agencies, accreditation agencies, or other parties. Pursuant to Section 1395x (v) (1) (I) of Title 42 of the United States Code with respect to any services furnished under the terms of this Agreement, if the value or cost of which is Ten Thousand and No/100 Dollars ($10,000.00) or more over a twelve (12) month period, until the expiration of four (4) years after termination of this Agreement, both parties shall make available, upon written request to the Secretary of the United States Department of Health and Human Services, or upon request by the Comptroller General of the United States General Accounting Office, or any of their duly authorized representatives, a copy of this Agreement and such books, documents, and records as are necessary to certify the nature and extent of the costs of the services provided by Institution employee(s) under this Agreement.21