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31 JANUARY 2018CLINICAL TRIALS GUIDANCE
LABELLING OF THERAPEUTIC PRODUCTS AND
MEDICINAL PRODUCTS USED IN CLINICAL TRIALS
GNCTB2003D003This guidance also applies to the labelling of Therapeutic Products
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How to fill out clinical trials guidance
How to fill out clinical trials guidance
01
Read the clinical trials guidance document carefully.
02
Understand the purpose and scope of the guidance.
03
Familiarize yourself with the regulatory requirements for conducting clinical trials.
04
Determine the type of clinical trial you are conducting (e.g., phase 1, phase 2, phase 3).
05
Follow the step-by-step instructions provided in the guidance for each section of the clinical trial application.
06
Provide all the required information and documentation as outlined in the guidance.
07
Ensure that the trial design, methodology, and statistical analysis plan align with the guidance.
08
Follow the ethical considerations and informed consent procedures mentioned in the guidance.
09
Submit the completed application and supporting documents to the appropriate regulatory authority.
10
Wait for feedback or approval from the regulatory authority before proceeding with the clinical trial.
Who needs clinical trials guidance?
01
Researchers conducting clinical trials
02
Pharmaceutical companies developing new drugs
03
Healthcare institutions and hospitals
04
Regulatory authorities overseeing clinical trials
05
Ethics committees reviewing and approving clinical trial protocols
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What is clinical trials guidance?
Clinical trials guidance provides instructions and recommendations for conducting clinical trials in a standardized and ethical manner.
Who is required to file clinical trials guidance?
All researchers and organizations conducting clinical trials are required to file clinical trials guidance.
How to fill out clinical trials guidance?
Clinical trials guidance can be filled out by providing detailed information about the study protocol, informed consent process, recruitment strategies, and data collection methods.
What is the purpose of clinical trials guidance?
The purpose of clinical trials guidance is to ensure that clinical trials are conducted in a transparent, ethical, and scientifically rigorous manner.
What information must be reported on clinical trials guidance?
Clinical trials guidance must include information about the study objectives, study design, participant eligibility criteria, and data analysis plan.
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