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Drug Accountability

Drug accountability is an important aspect of clinical research that ensures the proper handling, storage, administration, and disposal of investigational drugs. The objective of drug accountability is to maintain the integrity and quality of the investigational drugs, to prevent drug errors and adverse events, and to ensure that the study drugs are used only for their intended purpose.

The following are some of the key responsibilities related to drug accountability:

  1. Storage: The investigational drugs should be stored under appropriate conditions, such as temperature-controlled storage, to ensure their stability and quality. The storage conditions should be monitored and documented regularly.
  2. Administration: The investigational drugs should be administered according to the study protocol, using appropriate techniques and equipment, and under the supervision of a qualified healthcare provider. The administration should be recorded on the CRFs and other study documentation.
  3. Handling: The investigational drugs should be handled with care to prevent contamination, damage, or loss. The handling procedures should be described in the study protocol and the site standard operating procedures (SOPs).
  4. Record Keeping: The drug accountability records, such as the drug dispensation records, the drug storage logs, and the drug administration records, should be complete, accurate, and up-to-date. The records should be maintained for the duration of the study and for a specified period after the study completion.
  5. Disposal: The investigational drugs should be disposed of in a manner that is safe, environmentally friendly, and in compliance with applicable regulations. The disposal procedures should be described in the study protocol and the site SOPs.

Drug accountability is an ongoing process that occurs throughout the study, and it is critical to ensure the quality and integrity of the investigational drugs and to protect the rights, safety, and welfare of the study subjects. The drug accountability procedures should be performed by trained and qualified personnel, and they should be reviewed and audited regularly to ensure their effectiveness and compliance.

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