Common use of Reporting Serious Adverse Events Clause in Contracts

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 in the clinical trial database, including the Investigator’s assessment regarding the relationship of the SAE to the study drug. 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 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 should be retained in the site’s study files. In addition to CIOMS/MedWatch reports, the Sponsor will also notify (through annual updates to the Investigator Brochure) the Investigators and IRBs/IECs of all deaths that occur during the study, irrespective of relationship to study medication.

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 in on the clinical trial databasepatient’s AE eCRF, including the Investigator’s assessment regarding the relationship of the SAE to the study drugdrug (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 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 should be retained in the site’s study files. In addition to CIOMS/MedWatch reports, the Sponsor will also notify (through annual updates to the Investigator BrochureIB) the Investigators and IRBs/IECs of all deaths that occur during the study, irrespective of relationship to study medication.