Last Updated on March 6, 2024
Division of Pharmacy Services, DRAP, under Rule 20 of the Bio-Study Rules 2017 maintains a clinical trial registry for approved clinical trials involving human subjects being conducted in Pakistan.
Drug Regulatory Authority of Pakistan has recently adapted U.S. National Trial Registry as an international registry for all clinical trial approved by the Clinical Studies Committee, DRAP.
- Principal Investigators / Responsible parties (Sponsors) nominate a focal person from their organizations, to open & maintain PRS (Protocol Registration & Results System) account.
- All Principal Investigators / Responsible parties (Sponsors) will enlist their approved Clinical Trials on U.S. National Trial Registry and after getting “NCT” identifier number will inform to Division of Pharmacy Services-DRAP.
- NCT Number: The National Clinical Trial number is an identification that ClinicalTrials.gov assigns a study when it is registered. The NCT number is in the format “NCTXXXXXXXX”. Until an NCT number is assigned, the study is not registered on the U.S. National Trial registry.
Clinical Trials Subject Registry
A verifiable record of the clinical trial participants or subjects be maintained to stop duplicate enrolment and also to improve both patient safety and preserve data integrity of clinical trials. The subject identification shall be a closed information from the investigator, directly submitted to the DRAP.
Rejected Applications of Clinical Trials
The Drug Regulatory Authority of Pakistan (DRAP) has a stringent process for approving clinical trials. Applications may be rejected due to non-compliance with the rules, regulations, and procedures implemented by DRAP under the Bio-Study Rules, 2017. The detail of applications for clinical trials rejected by the Clinical Studies Committee are as under: –
[table “27” not found /]