Reporting Serious Adverse Events. All serious adverse events during the study period, whether or not considered to be related to study treatment must be reported to the respective CRO that is managing the site within 24 hours or, at the latest, on the following working day. At the time of the initial report, as much information as possible should be provided: patient allocation number, treatment, study identifiers, the phase of treatment during which the event occurred, a description of the event, its date of onset and current status; the start date, the start time, whether this treatment has been discontinued; the reason why the event is regarded as serious; the current assessment of causality, investigator's name and address. The investigator must fax the SAE form within the next 24 hours if it is not provided at the time of the initial notification. Any other diagnostic information, which will assist the understanding of the event should be provided at this time. The study patient has to be followed until the final outcome of the SAE is known, including any which are still ongoing at the end of the study. Significant new information on the SAE, and the final outcome, must be supplied promptly to the respective CRO that is managing the site. This should be done in the same way and time frame as for the original notification, using the SAE form and identifying this as follow up information. The investigator must report promptly any SAEs, which may be detected after the study, and are suspected to be related to study treatment. Investigators must report all SAEs to the IRB according to their institutional policy. 11 REGULATORY REQUIREMENTS
Reporting Serious Adverse Events. All Serious Adverse Events (SAEs) must be reported immediately by the Investigator without filtration, whether considered to be associated with BL-1040 and whether or not considered related to BL-1040. The Investigator must report SAEs within one calendar day of becoming aware of the event by telephone, fax or e-mail to the Study Contact for Reporting Serious Adverse Events as indicated below. This initial notification should include minimal, but sufficient information to permit identification of the reporter, the patient, study device, any medications administered, AEs, causality assessment and date of onset. The Investigator should not wait for additional information to fully document the event before providing notification. An acknowledgement letter will confirm the first notification. The report is then to be followed by submission of a completed SAE Report Form provided by Averion International as soon as possible but at latest within 3 calendar days of the initial telephone/fax or e-mail report detailing relevant aspects of the AEs in question. All actions taken by the Investigator and the outcome of the event must also be reported immediately. For documentation of the SAE, any actions taken, outcome and follow-up reports, the SAE Report Forms are to be used. Where applicable, hospital case records and autopsy reports should be obtained. Investigators must report SAEs to the appropriate ethics committee if requested by the committee and/or according to local legal requirements. Fax: e-mail: Tel: Averion International Xxxxxxxxxxxxxx 00, XX-0000 Xxxxxxxxx, Xxxxxxxxxxx +00-00-000-0000 XXX@xxxxxxxxxxx.xxx +00-00-000-0000 24/24 hour and 7/7 day availability Annotated Protocol incorporating Amendment 1, Amendment 2, Amendment 3, and Amendment 4 01 December 2008 Protocol BL-1040.01, Version 5.00 Safety and Feasibility study of BL-1040 Final CONFIDENTIAL
Reporting Serious Adverse Events. Any SAE, regardless of relationship to study medication, which occurs in a patient from the time of study informed consent until 30 days after the last study treatment, must be recorded by the clinical site on an SAE report form. Only SAEs which are considered related to a study procedure (ie blood draw or fresh tumor biopsy) will be captured during the pre-screening period, ie from the time of signing the pre-screening consent (if one is utilized) until the signing of the main study informed consent, or until the patient is determined to be a screen failure. The SAE must also be recorded on the patient’s AE eCRF, including the Investigator’s assessment regarding the relationship of the SAE to the study drug (MIRV, Pac, PLD, or Topo). The Investigator will promptly supply all information requested by the Sponsor (or contract research organization [CRO]) regarding the SAE. The Investigator must submit the SAE Report Form to ImmunoGen Pharmacovigilance (or designee). This form must be completed and submitted within 24 hours of the Investigator’s learning of the event using the contact information printed on the SAE form and contained within the SAE form completion instructions. Follow-up information must also be submitted using a new SAE Report Form. When reporting SAEs, the following additional points should be noted: • The underlying diagnosis or syndrome should be reported as the primary SAE term, rather than the signs or symptoms (signs and symptoms may be described in the narrative). • An event term of “Death” should not be reported as an SAE, but rather be recorded as an outcome of a specific SAE term. Initially, the event term of “death” can be used until the actual cause of death is known. If an autopsy was performed, the autopsy report should be provided. It is the responsibility of the Sponsor to ensure that each Investigator receives a copy of any suspected unexpected serious adverse reaction (SUSAR) report (CIOMS/MedWatch) regarding the study drug and that the report is submitted to the appropriate national regulatory agencies. The Investigator (or Sponsor or contracted designee) must promptly report all SUSARs to the Institutional Review Board/Independent Ethics Committee (IRB/IEC) for review in accordance with national regulations. IRB/IEC notification of the SUSAR may take the form of a submission of a copy of the CIOMS/MedWatch report or other format accepted by the IRB/IEC. A copy of the CIOMS/MedWatch report and notification to IRB/IEC shou...
Reporting Serious Adverse Events. Any AE the investigator considers serious according to the previously described criteria must be reported within 24 hours from the time the site personnel first learn about the event. The eCRF system within the clinical database is the preferred method of reporting an SAE. To report the SAE, the investigator will complete the SAE form in the clinical database and submit (Refer to Table 6) within 24 hours of awareness. If the clinical database is down for any reason, the manual SAE forms should be used; however, sites are responsible for ensuring the information on the manual SAE forms is entered into the clinical database once available. Table 6: SAE Reporting Contact Information
Reporting Serious Adverse Events. Any AE the investigator considers serious according to the previously described criteria must be reported within 24 hours from the time the site personnel first learn about the event. To report the SAE, fax the completed SAE form to (fax numbers listed in Table 7) within 24 hours of awareness.
Reporting Serious Adverse Events. In order to adhere to all applicable laws and regulations for reporting an SAE(s), the study site must notify Sage or designee within 24 hours of the study site staff becoming aware of the SAE(s). The investigator must complete, sign and date the SAE report form, verify the accuracy of the information recorded on the SAE report form with the corresponding source documents, and send a copy to Sage or designee. Additional follow-up information, if required or available, should all be sent to Sage or designee within 24 hours of receipt on a follow-up SAE report form and placed with the original SAE information and kept with the appropriate section of the eCRF and/or study file. Serious adverse events occurring after the designated follow-up time for the study, should be reported to Sage or designee according to the timelines noted above only if the investigator considers the SAE related to IP. Sage, or designee, is responsible for notifying the relevant regulatory authorities of certain events. It is the principal investigator’s responsibility to notify the IRB/IEC of all SAEs that occur at his or her site. Investigators will also be notified of all suspected unexpected serious adverse reactions (SUSARs) that occur during the clinical study. IRBs/IECs will be notified of SAEs and/or SUSARs as required by local law. In addition, appropriate personnel in Sage Drug Safety and Pharmacovigilance or designee will unblind SUSARs for the purpose of regulatory reporting. Sage or designee will submit SUSARs (in blinded or unblinded fashion) to regulatory agencies according to local law. Xxxx, or designee, will submit SUSARS to investigators in a blinded fashion.
Reporting Serious Adverse Events. All SAEs (related and unrelated) occurring from screening through 28 days after the last study drug dose are to be reported. Any suspected case of pneumonitis, considered an adverse events of special interest, should be reported in the same manner as an SAE. The Investigator must report all SAEs within 24 hours of discovery via the EDC system, which will trigger email notifications to the ProSciento, Inc., Medical Monitor/Safety team. (In the event the EDC system is not available, then SAE reports must be emailed to 0XXXXXxxxxx@XxxXxxxxxx.xxx.) The Investigator must complete and electronically sign and date the SAE pages of the eCRF and verify the accuracy of the information recorded on the SAE pages with the corresponding source documents. Additional follow-up information, if required or available, should be submitted within the EDC system within one business day of receipt and this should be completed on a follow-up SAE form and placed with the original SAE information and kept with the appropriate section of the eCRF and/or study file. Sagimet Biosciences is responsible for notifying the relevant regulatory authorities of certain events. It is the Investigator’s responsibility to notify the IRB of all SAEs that occur at his or her study center. Investigators will also be notified of all unexpected, serious, drug-related events (7/15 Day Safety Reports) that occur during the clinical study. Each study center is responsible for notifying its IRB of these additional SAEs.
Reporting Serious Adverse Events. A SAE CRFmust be completed with as much information available within 24 hours of knowledge of the event. To improve the quality and precision of acquired SAE data, Clinical Investigators should observe the following guidelines: • Death - Death is an outcome of an event. The event that resulted in the death should be recorded and reported as a SAE.
Reporting Serious Adverse Events. It is the responsibility of the Investigator that reporting is done adequately. In order to meet Regulatory reporting timelines, the study site is obligated to report any SAE(s) to the Sponsor or designee immediately and no later than 24 hours after receiving information of an event that meets at least one of the criteria for seriousness as defined in Section 11.2.2. Refer to the SAE Reporting Plan for further details on the submission of SAE Reports.
Reporting Serious Adverse Events. Any SAE (fatal or life-threatening SAE and other SAEs), whether or not related to the study drug, must be reported immediately within 24 hours of the investigator’s awareness of the event by telephone and faxing the appropriate SAE forms to the CRO. Local reporting requirements other than described, will be taken into account and adhered to.
