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CONDUCT OF CLINICAL TRIALS GUIDELINESDocument History: 1st Edition Effective Date:Drug Regulatory Authority of Pakistan GOVERNMENT OF PAKISTAN Telecom Foundation Complex, Sector G9/4, Islamabad. HISTORYThis
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How to fill out conduct of clinical trials

01
Determine the objectives of the clinical trial.
02
Obtain approval from the ethics committee or institutional review board.
03
Design the trial protocol, including participant eligibility criteria, study interventions, and outcome measures.
04
Recruit and enroll participants according to the eligibility criteria.
05
Obtain informed consent from the participants or their legal representatives.
06
Randomize participants to different treatment groups, if applicable.
07
Administer the study interventions and collect data on outcomes.
08
Monitor participants for adverse events and report them as required.
09
Analyze the data collected and draw conclusions.
10
Prepare a final report of the trial findings.
11
Submit the trial results to relevant regulatory authorities, if required.

Who needs conduct of clinical trials?

01
Pharmaceutical companies developing new drugs or medical devices.
02
Academic researchers studying the effectiveness of interventions.
03
Government agencies regulating the approval and marketing of medical products.
04
Healthcare institutions evaluating the safety and efficacy of treatments.
05
Non-profit organizations conducting public health research.

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Conduct of clinical trials refers to the systematic process of planning, executing, and managing clinical studies to evaluate the safety and efficacy of new drugs, treatments, or interventions on human subjects.
Sponsors of clinical trials, which can include pharmaceutical companies, biotechnology firms, and academic institutions, are required to file conduct of clinical trials.
Filling out conduct of clinical trials involves completing standardized forms provided by regulatory authorities, including details about the study design, methodologies, participant eligibility, informed consent processes, and safety measures.
The purpose of conduct of clinical trials is to gather data on the effectiveness and safety of new treatments, ultimately leading to regulatory approval and improved health outcomes for patients.
Information reported on conduct of clinical trials includes study objectives, design, participant demographics, intervention details, primary and secondary outcomes, data analysis plans, and safety and adverse event reporting.
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