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SOP3.5 Investigational drug accountability, storage, dispensing and return Approved Date: 3/04 Reviewed/Revised Date: 8/05, 3/06, 9/08, 12/08, 7/09 Owner: Research Pharmacist Page 1 of 7 CTO SOP 3.5

How to fill out sop35 investigational drug accountability

How to fill out SOP35 Investigational Drug Accountability:

1. Begin by gathering all necessary information and documents related to the investigational drug. This may include packaging information, batch numbers, drug labels, and any related forms or records.
2. Comply with any specific instructions or guidelines provided by your organization or regulatory bodies. Ensure that you understand the requirements and protocols for filling out the SOP35 investigational drug accountability form.
3. Clearly identify the investigational drug being accounted for. Include details such as the drug name, dosage strength, and any unique identifiers or codes assigned to the drug.
4. Record the date and time of the drug's receipt, as well as the location where it was received. This helps in tracking the drug's movement and ensures accurate accountability.
5. Document information regarding the drug's storage. Record details such as the temperature range at which it is stored, the storage area or room number, and any specific precautions or requirements for storing the drug.
6. Maintain a detailed log of the drug's usage or dispensing. This includes documenting the date and time of administration, the quantity used or dispensed, and the names or identification of the individuals involved in the process.
7. Document any instances of drug waste or destruction following proper protocols. This includes recording the quantity of drug wasted or destroyed, the reason for its disposal, and any relevant approvals or authorizations for such actions.
8. Keep track of any drug returns or transfers. If the investigational drug is returned to the pharmacy or transferred to another location, record the date, time, quantity, and details of the transaction.
9. Complete any required sections or fields on the SOP35 investigational drug accountability form accurately and legibly. Double-check all entries for errors or omissions before finalizing the record.
10. Finally, ensure that the completed SOP35 investigational drug accountability form is stored in a secure and organized manner for future reference or audits.

Who needs SOP35 Investigational Drug Accountability?

1. Pharmaceutical companies conducting clinical trials.
2. Research institutions or centers involved in investigational drug studies.
3. Healthcare facilities or hospitals that participate in clinical research.
4. Regulatory bodies overseeing drug trials and compliance.
5. Contract research organizations managing clinical trials.
6. Pharmacists and pharmacy personnel responsible for handling investigational drugs.
7. Investigators and research staff involved in administering investigational drugs to study participants.
8. Quality assurance and regulatory compliance personnel.

Note: The specific individuals or organizations that require SOP35 Investigational Drug Accountability may vary depending on the jurisdiction, trial protocol, and organizational policies in place. It is essential to consult your specific institution's guidelines and regulatory requirements to determine who needs to comply with SOP35.

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