NIAID Investigational Product Accountability Record Form G 2016-2026 free printable template

INVESTIGATIONAL PRODUCT ACCOUNTABILITY RECORD (FORM G) Clinical Research Site Nonclinical Research Site NumberInvestigator of Record NameProtocol NumberInvestigational Product Name:Strength and Dosage

How to fill out NIAID Investigational Product Accountability Record Form

How to fill out NIAID Investigational Product Accountability Record Form G

1. Obtain the NIAID Investigational Product Accountability Record Form G from the NIAID website or your study's regulatory documents.
2. Fill in the protocol number and title at the top of the form.
3. Enter the investigational product details including the name, lot number, and expiration date.
4. Record the initial quantity of the product received at the study site.
5. Document the dates and quantities of all dispensed products to participants.
6. Note any product returns to the sponsor or any inventory adjustments due to errors or lost product.
7. Ensure that all entries are signed and dated by the person responsible for the documentation.
8. Review the completed form for accuracy and completeness before submission.

Who needs NIAID Investigational Product Accountability Record Form G?

1. Researchers conducting clinical trials involving investigational products.
2. Clinical trial sites that are accountable for the tracking and management of investigational products.
3. Regulatory bodies that require documentation for compliance and safety monitoring.

People Also Ask about

What is an investigational drug data sheet?

This patient is a participant in a clinical trial. This form contains information about the investigational drug and comparator agents being utilized in the study protocol.

Who is responsible for investigational product accountability?

General Responsibilities: It is the responsibility of the Principal Investigator (PI) at the site of a clinical trial to ensure accurate and complete accountability and proper storage of investigational drugs/products used in a clinical trial.

Where should the final information about the dispensing of an investigational product be recorded?

The accountability log should indicate the date, amounts, batch numbers, and conditions at receipt for all materials received from the supplier. Each time study product is dispensed from the pharmacy to a participant, the occurrence should be thoroughly documented in the accountability log.

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.

What is the investigational drug accountability record?

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.

Where is information on storage requirements for the investigational product?

Investigational Products should be stored within the temperature requirements of the Investigator's Brochure, packaging insert or other authoritative document.

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What is NIAID Investigational Product Accountability Record Form G?

The NIAID Investigational Product Accountability Record Form G is a document used to track and report the receipt, use, and disposition of investigational products in clinical trials conducted under the National Institute of Allergy and Infectious Diseases (NIAID).

Who is required to file NIAID Investigational Product Accountability Record Form G?

Investigators, study coordinators, and institutional staff involved in the management of investigational products for relevant clinical trials are required to file the NIAID Investigational Product Accountability Record Form G.

How to fill out NIAID Investigational Product Accountability Record Form G?

To fill out the form, users should provide detailed information including the product name, lot number, quantity received, inventory records, and records of product dispensation. Each entry must be dated and signed by the responsible personnel.

What is the purpose of NIAID Investigational Product Accountability Record Form G?

The purpose of the form is to ensure proper accountability and traceability of investigational products used in clinical trials, thereby supporting compliance with regulatory requirements and maintaining the integrity of the trial.

What information must be reported on NIAID Investigational Product Accountability Record Form G?

The form must report information such as product identification details, dates of receipt and disposal, quantities received and used, lot numbers, and signatures of authorized personnel involved in managing the investigational product.