At the beginning of the clinical trial, the sponsor, the investigator and the clinical trial organization should establish the file management of the necessary documents.
Copies of the application form, the document approving the clinical trial by the drug administration department and the ethics committee and the summary report of the clinical trial, copies of the coded directory of subjects, the informed consent form, the case report form and the relevant diagnostic examination data, and the record of drug handling.
The retention period is at least two years after the test drug is approved for marketing or at least two years after the termination of the clinical trial of the test drug. The retention period may also be extended if management needs or by agreement between the investigator and the sponsor.
The sponsor should keep the documents related to the clinical trial, including the report to the drug administration, the trial protocol, the drug administration's approval, a copy of the ethical committee's approval documents, the summary report of the clinical trial, the case report form, the contract, and the record of serious adverse reactions and serious adverse events.
Clinical trial is introduced as follows:
Clinical trial (Clinical trial) is to evaluate the efficacy and safety of the drug, vaccine, device or other medical measures, the use of tracking, observation, statistics and other means of systematic design and implementation of the study.
A clinical trial of a drug is any systematic study of a drug in humans (patients or healthy volunteers) to confirm or discover the clinical, pharmacological and or other pharmacodynamic effects, adverse reactions and/or absorption, distribution, metabolism, and excretion of the test drug, with the aim of determining the safety and efficacy of the test drug. Drug clinical trials are generally categorized into phase I, II, III and IV clinical trials and drug bioequivalence tests and human bioavailability.
Phase I clinical trials are followed by phase II clinical trials, which are the first controlled clinical studies of a drug, and the number of patients involved is usually within a few hundred, and the main purpose of the trials is to determine the dosage ranges and dosages for phase III clinical trials, in addition to initially evaluating the efficacy of the drug for a particular indication, or multiple indications for a particular disease, based on the clinical endpoints, and to determine the common short side effects and the risks associated with dosing.