Clinical Research Application

Application to conduct a clinical trial

Please submit the following:

• One complete Research Application Dossier containing original hard copies of all documents.
• One soft copy of the complete research application documents (via email).
• Three sets of Abbreviated Dossier containing Research Application Form, Protocol, Information Sheet/Consent Form, Investigator’s Brochure.

For dossiers submitted in hard copy, please ensure that proper index dividers are inserted for easy referencing.

Please provide any relevant supporting documents, e.g:

• Advertisements
• Questionnaires
• Investigator’s brochure and product summary
• Investigator(s)’ curriculum vitae and GCP certificates
• Recruitment material
• Insurance coverage for subjects in event of trial-related injury
• Statement from trial sponsor indemnifying the relevant staff, investigator, institution and IEC

All new applications are to be submitted with a one-off application fee of RM 1,500 per research project made payable to SJP Medical Centres Sdn Bhd - SJMC.

Submission criteria for clinical research

• At least one study team member should be trained/certified in Good Clinical Practice (GCP).
• Applications will only be processed upon receipt of full payment
• Informed consent form based on WHO and GCP recommendations
• Informed consent checklist
• Application forms are available from the IEC Member Secretary
• Please ensure application forms are typewritten
• Subjects shall only be enrolled in a trial after written approval of the trial from IEC, and no subject shall be admitted to a trial before the IEC issues written approval/favourable opinion of the trial

Researchers’ responsibilities from the World Health Organisation

Standards and operational guidance for ethics review of health-related research with human participants 2011

Research is performed only by persons with scientific, clinical, or other relevant qualifications appropriate to the project, who are familiar with the ethical standards applicable to their research, who submit the necessary information to the Research Ethics Committee (REC) for review (including both the research protocol and disclosures of any conflicting interests), and who carry out the research in compliance with the requirements established by the REC.

• An application or review of the ethics of proposed health-related research is submitted by a researcher qualified to undertake the particular study, who is directly responsible for the ethical and scientific conduct of the research. In certain jurisdictions, the sponsor of a study is responsible for submitting the research protocol to the REC.
• Student applications are submitted under the responsibility of a qualified advisor or faculty member involved in the oversight of the student’s work or in the student’s name, co-signed by the qualified faculty supervisor.
• All information required for a thorough and complete review of the ethics of proposed research is submitted, including disclosures about researchers’ conflicting interests, if any.

Review of new clinical trial applications

Applicants will be notified of the date and time of the IEC meeting (at least 7 days in advance) where the application is to be reviewed.

The investigator will be required to attend this meeting to present the research submission and answer queries from IEC members.