Records of investigational drug management should include date, quantity, batch number/serial number, validity period, distribution code, signature, etc.

The purpose of the experimental drug management system is to establish operating procedures for the receipt, counting, distribution, use, and storage of experimental drugs, so as to normalize and standardize operations. Scope: Applicable to all clinical trials. Responsible Person: Personnel responsible for drug storage during clinical trials. Operating Procedures: The sponsor is responsible for receiving investigational drugs and providing them.

When receiving the investigational drugs, the researcher checks: whether the packaging and labeling of the investigational drugs provided are appropriate and whether they are marked as exclusive for clinical trials; whether there is a drug inspection report; whether the investigational drugs and control drugs (have been whether the appearance, smell, packaging, labeling, and other characteristics of the official product approved for marketing) or the placebo are consistent. According to the agreement, check the name, dosage form, specification, expiration date, manufacturer, batch number and quantity of the trial drug.

The recipient registers and signs on the receipt record. Counting of investigational drugs: The counting of investigational drugs should include the following records: name, quantity, receipt time of investigational drugs; dosage form and dosage, batch number and expiry date; storage conditions and precautions; blinding envelopes and blinding principles (Phase I) Generally not used in clinical trials); count of drugs received and returned to the sponsor.

Distribution of investigational drugs: The drug custodian shall keep detailed records of the distribution of investigational drugs, including: the initials and codes of the subjects receiving the drugs; the quantity, packaging number and date of distribution; medication use Start and stop times; usage and dosage; records and explanations of other situations when distributing drugs, such as misuse, loss, etc.