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Click ‘Get Form’ to open the accountability log template in the editor.
Begin by entering the Study Code and Study Name at the top of the form. This information is crucial for identifying your specific study.
Fill in the Site Number and Investigator Name in the designated fields. Accurate details here ensure proper tracking of drug supply and usage.
Record the Amount of Aromasin® received, including the Date and Lot Number. This section helps maintain a clear inventory of drug supplies.
In the next section, document the Amount of Aromasin® used along with its corresponding Date and Lot Number. This is essential for monitoring drug administration.
For any destroyed drugs, note down the Amount destroyed, Date, Lot Number, and action taken. This transparency is vital for compliance.
Finally, provide any comments regarding discrepancies or issues in the Comments section. This allows for thorough documentation of any irregularities.
Ensure to sign and print your name along with the date at the bottom of the form to validate your entries.
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Dispensing IP refers to the distribution of IP to subjects as per study protocol. Returning IP refers to the returning of unfinished/ unused/ used up IP from subject to site, and from site to Sponsor.
What is an accountability log?
A log of study drugs kept by an investigator running a clinical trial. It lists many things about each drug, including the drug name, lot number, expiration date, the amount of drug received, used, returned, or thrown away, and the amount left.
How to build an accountability chart?
How to Create an Accountability Chart Identify Your Organizations Key Functions. Define Roles for Each Function. Assign Accountability. Organize the Chart. Review and Adjust. Implement and Communicate.
Is there an org chart template in Word?
An Accountability Diagram (or chart or matrix) provides a functional view of the organization and identifies the accountability along with the roles and responsibilities of each member within the function. An application-oriented question on the topic along with responses can be seen below.
What is an IP accountability log in clinical trials?
The Drug or Device Accountability Log is a means to track and document when and how the investigational product (drug or device) has been used throughout the study.
Aug 7, 2018 FDA Essential and Vital Records must be identified and protected from potential loss. The protection method required is based on record media
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