JPEC

• JPEC informs applicants of its decision in writing within 14 days from its review. In cases of a full approval, a statement of responsibilities of the investigator is provided. In cases of negative decisions (i.e rejected, termination), reasons are provided.
• JPEC approvals for new research projects are valid for 12 months from the date of issue of the JPEC Decision Notification Form. A new application to JPEC will have to be submitted for research projects that are not commenced within 12 months from the date of issue of the JPEC Decision Notification Form.
• In some instances, JPEC grants conditional approvals. In these cases applicants must show evidence that they have complied with these conditions within 8 weeks from this notification to receive a full approval. After that date, the file on this application will be closed if no response is received by JPEC. A new application will need to be submitted if the applicant is keen on pursuing ethical approval.

All adverse drug reactions (ADRs), which are both serious and/or unexpected, are to be reported to JPEC. In the case of 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, using the JPEC Serious Adverse Event Report.

For SAEs outside of the investigator’s institution (applicable in multicentre trials):

• Only Suspected, Unexpected and Serious Adverse Reaction (SUSAR) are to be submitted to JPEC
• Those that are fatal/life-threatening : Investigator is to report (cc. local investigator) the SUSAR to JPEC within 7 calendar days from first knowledge by the INVESTIGATOR. 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 by the INVESTIGATOR.
• Only protocol specific investigational product(s) SUSARs are to be submitted to JPEC.
• All periodic SUSAR reporting (line listing) are to be accompanied by a brief report by sponsor highlighting main points of concern, if any.
• Annual Safety Report is expected on an annual basis throughout the whole clinical trial course. This report will describe concisely all new safety information relevant for the trial and to assess the safety conditions of subjects in the trial.

After JPEC has issued ethical approval for a trial to begin, it continues to monitor the trial to ensure that the subjects’ welfare, safety and rights are protected through the dynamics of time. This is done by receiving notification from investigators of the following:

• Amendments to the trial
• Reports – serious adverse event, trial progress and closure reports
• Or by conducting an audit of the trial

A Research Project Progress Report is to be submitted to JPEC at specified intervals (usually annually) once a trial is ongoing. Upon study closure, a Research Project Closure Report is to be submitted to JPEC. Normally, the first research project progress report is due one year from the date of issue of the JPEC Decision Notification Form. However, studies with higher risk to subjects may require more frequent progress reporting. The Research Progress report is not applicable to short studies, which are closed within a year from date of issue of the Decision Notification Form. In this instance, only the study closure report needs to be submitted o JPEC.

Investigator(s) involved in ongoing trial(s) are required to submit to JPEC their most recent, updated Curriculum Vitae and Annual Practicing Certificate annually (beginning of each year) until JPEC is notified of study or site closure.

If the applicant perceives a request for amendment, substantial change, resubmission or non approval unfair or unwarranted, the applicant will initially confer with the Secretary for clarification of the reasoning of JPEC.

If, after consultation with the Secretary, the applicant is not satisfied, the applicant has the right to request, and JPEC is obligated to provide reconsideration of negative decision through an appeal process.

Only appeals that are made in writing will be considered. Letters of appeal must be received within 30 days in advance of the next scheduled JPEC meeting.

The appeal process would involve four steps

• A discussion of the issue appealed
• A review of the evidence
• A considered decision arrived at
• Communication of the decision outcome made during a convened meeting
  JPEC may invite the appellant to attend the meeting

The decision of the appeal is based on

• A full and clear understanding of the facts of the original review
• The nature of the appeal
• Legal opinion
• Adherence to the ICH and Malaysian Guideline for GCP
• Adherence to JPEC SOPs
• Attention to the internal and external reputation of Penang Medical College and Info Kinetics Sdn Bhd Clinical Research Centre

The outcomes to appeal would include

• Whether the appeal is successful or not
• Reasons for the decision
• Communication of the decision is within 7 days of the meeting
• JPEC’s decision is final