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Yes upon termination of your study, you are required to send in a Closure Report to JPEC within within 15 days with reasons for suspension/termination and a summary of results provided....

Yes upon completion of your study, you are required to send in a Closure Report Form to JPEC within 90 days of scheduled study closure....

The JPEC approval is only valid for 12 months from the date of the approval letter issued....

JPEC requires to be indemnified as JPEC is not affiliated under any institution and on its own is an independent body therefore is not indemnified against claims arising from the trial, except for claims that arise from malpractice and/or negligence. JPEC can be indemnified in a separate indemnity letter or in a paragraph in the CTA agreement....

JPEC shall give an opinion within a maximum of 35 days of the date of receipt of the valid and completed proposed amendment submitted....

Protocol deviation involving JPEC approved sites needs to be reported through a cover letter signed by the Investigator....

There is no timeline for the submission of SUSAR line listings. However, all applicants are required to submit the line listing whenever one is available from the sponsor. All periodic SUSAR reporting (line listing) are to be accompanied by a brief report by sponsor highlighting main points of concern, if any...

For serious adverse events (SAEs) occurring in the investigator’s institution, the investigator is to notify the JPEC Chairperson within 24 hours of its notification to the investigator. Investigator is to report (cc. local investigator) the fatal/life-threatening SUSAR to JPEC within 7 calendar days from first knowledge. If there is additional information, this should be submitted within 8 calendar days. Those that are non-fatal/life-threatening SUSARs,...

Yes. You only need to report related and unrelated SAEs of sites approved by JPEC only but SUSARs from all over the world. Reporting is done specific to the research protocol....

Yes. Please refer to the form attached here...