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.