What are the 10 simplified dossiers for the initial application?
A simplified dossier is similar to that of the full dossier except the simplified dossier would not need to include the following documents:
- Investigator Brochure
- Insurance Policy
- Application Form
What are the procedures for application for multiple sites?
For a single protocol with multiple sites, only one application form is needed for the initial application and also application for amendment and need to be signed by the Corresponding PI. For addition of sites to an already approved protocol, a copy of the Principal Investigator’s CV, Annual Practicing Certificate and GCP certificate would need to be submitted along with the site specific documents.
What are usually the main conditions not met for full approval?
Some of the common conditions for approval for approval not met are: i) ICF does not contain the applicable requirements according to the Applicant’s checklist of minimum requirements in the informed consent form and written subject information. ii) Doctor’s name advertised in patient recruitment advertisements and materials iii) Incomplete document submitted (i.e no indemnity letter) iv) The coverage of medical fees through healthcare insurance provider in the informed consent form which is not applicable in Malaysia v) Principal Investigator is not certified in Good Clinical Practice for interventional clinical trials. vi) ICF are in mixed languages
Do I need to include a template of a case report form in the submission of a new application?
Documents (besides the protocol and Investigator Brochure) that are not distributed to patients and are not source documents need not to be submitted to JPEC as JPEC do not review documents those documents. However, the applicant is still allowed to submit a copy of those documents (i.e JPEC acknowledges the submission) but an approval will not be issued as it did not undergo a review.
Is there any JPEC template for SAE reports?
Yes. Please refer to the form attached here
Do we need to report SAEs of sites approved by JPEC only?
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.
What is the timeline to submit local SAEs & SUSARs?
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, to submit to JPEC within 15 calendar days from first knowledge.
What is the timeline to submit SUSAR line listings?
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
What about protocol deviation?
Protocol deviation involving JPEC approved sites needs to be reported through a cover letter signed by the Investigator.
How long will it take to approve an amendment?
It will take up to 15-20 days for an amendment involving non-substantial/ less than minimal risk changes. Amendments affecting the safety of trial subjects would usually be tabled in a meeting review and would take around 20-25 days.
Does JPEC requires to be indemnified?
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.
How long is the ethical approval valid for a particular study?
The JPEC approval is only valid for 18 months from the date of the approval letter issued.
What happens if I have completed my study? Do I need to inform JPEC?
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.
What happens if my study is terminated? Do I need to inform JPEC?
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.