Get the free investigational product accountability form

This document is used to account for investigational products used in clinical trials, detailing dispensing, balance, and returns of the products.

How to fill out investigational product accountability form

How to fill out investigational product accountability form

1. Obtain a copy of the investigational product accountability form from the study protocol or clinical trial documents.
2. Fill in the study identifier and site information at the top of the form.
3. List all investigational products being accounted for, including their batch/lot numbers.
4. Document the quantity of each investigational product received, dispensed, and returned, along with the corresponding dates.
5. Ensure that all entries are accurate and complete, and double-check for any discrepancies.
6. Record any product wastage and explain the reasons for it in the designated section.
7. Signature and date at the bottom of the form to confirm the accuracy of the recorded information.

Who needs investigational product accountability form?

1. Clinical trial sites to maintain accountability of investigational products.
2. Investigators and study coordinators who oversee the use of investigational products.
3. Regulatory authorities during inspections to ensure compliance with trial regulations.
4. Sponsor organizations to monitor inventory and ensure safety protocols are followed.

What is ip accountability log template Form?

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Template ip accountability log template instructions

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ip accountability log template: frequently asked questions

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People Also Ask about

What is investigational product accountability?

Investigational Product Accountability: Includes documentation of the following on an ongoing basis: When drug supplies arrive. When a drug is dispensed. When a drug is returned by a subject.

Who is responsible for product accountability?

Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution. The Investigator is responsible to ensure control of investigational product.

What does IP mean in clinical trials?

Investigational Product, or IP, is: · a pharmaceutical form of an active ingredient, or, · a placebo being tested or used as a reference in a clinical trial, · including a product with a marketing authorization when used or assembled.

What is IP accountability log in clinical trials?

Investigational Product Accountability Log: Subject Record. Purpose: To document all study product disposition and accountability on the subject level. Audience/User: Study Coordinators, Principal Investigators (PIs), pharmacy staff, other site staff, clinical monitor.

What is product accountability?

Product Accountability. Product accountability is a critical component of the manufacturing process. For manufacturing and quality assurance and safety outcomes, heavily-regulated industries like the aerospace, automotive and medical sectors require heightened oversight and compliance standards.

What is investigational product IP?

An investigational product is a drug, biological product, device, or placebo being tested or used in a clinical trial. Typically investigational products are either unapproved by the FDA or being used in a way different from what is already approved.

For pdfFiller’s FAQs

What is investigational product accountability form?

The investigational product accountability form is a document used in clinical trials to track the receipt, use, and return of investigational products to ensure proper accountability and compliance with regulatory requirements.

Who is required to file investigational product accountability form?

Investigator sites, study coordinators, and any personnel involved in the management and oversight of the investigational product are required to file the investigational product accountability form.

How to fill out investigational product accountability form?

To fill out an investigational product accountability form, one must enter details such as the product name, lot number, quantity received, quantity dispensed, quantity returned, and signatures of the personnel responsible for handling the product.

What is the purpose of investigational product accountability form?

The purpose of the investigational product accountability form is to maintain accurate records of the investigational product's lifecycle, ensuring its integrity, proper storage, and adherence to study protocols and regulatory guidelines.

What information must be reported on investigational product accountability form?

The information that must be reported includes product description, lot number, quantity received, quantity dispensed to participants, quantity returned, date of transactions, and signatures of authorized personnel.