VA Form 10-9012: Investigational Drug Information Record

VA Form 10-9012: Investigational Drug Information Record – VA Form 10-9012, officially titled the Investigational Drug Information Record, is a critical document used in Veterans Affairs (VA) medical research involving investigational drugs. It ensures safe handling, dispensing, and administration of study drugs while protecting Veteran participants.

This article explains the form’s purpose, who needs it, how to complete it, and where to download the latest version. It is especially relevant for VA researchers, principal investigators (PIs), pharmacists, and IRB members.

What Is VA Form 10-9012?

VA Form 10-9012 is the official Investigational Drug Information Record used by the U.S. Department of Veterans Affairs. It provides essential drug information to pharmacists, prescribers, nurses, and other clinical staff involved in VA-approved research studies.

The form communicates key details about an investigational drug (or an FDA-approved drug used for an unapproved purpose) to support safe patient care. It is required under VHA Handbook 1108.04 on Investigational Drugs and Supplies.

Download the official form here:
Download VA Form 10-9012 PDF (Revision date: November 1989, still current as of latest VA resources).

Purpose of the Investigational Drug Information Record

The primary purpose of VA Form 10-9012 is to bridge communication between the Principal Investigator and the VA Pharmacy Service. It informs authorized personnel about:

  • Drug identification and source
  • Storage, stability, and preparation instructions
  • Administration routes and dosages
  • Known side effects, toxicities, and antidotes
  • Special precautions (including drug interactions)
  • Contact information for emergencies or questions
  • Authorized prescribers

This ensures compliance with FDA regulations, IRB requirements, and VA policies for human subjects research involving investigational agents.

Who Must Complete VA Form 10-9012?

  • Principal Investigators (PIs) or Responsible Investigators leading VA research protocols that involve investigational drugs.
  • Required for studies using drugs under an Investigational New Drug (IND) application or off-label use of approved drugs in research.
  • The form must be reviewed and signed by the IRB Subcommittee on Human Studies and the Research and Development (R&D) Committee.

Note: Even if a manufacturer’s package insert exists, the VA Form 10-9012 (or equivalent) is typically still required for investigational use.

Key Sections of VA Form 10-9012

The one-page form includes structured fields such as:

  • Study and Investigator Information — Title of study, responsible and principal investigator.
  • Drug Details — Generic/chemical names, trade names, manufacturer/sponsor, source, therapeutic class, expected effects, dosage forms, and strengths.
  • Storage and Stability — Requirements before/after mixing, temperature, protection from light.
  • Administration — Routes (e.g., IV, oral), dosage range, reconstitution directions.
  • Safety Information — Side effects/toxicities, special precautions, antidote, double-blind status, and emergency contacts.
  • Status — Phase I, II, III, or commercially available.
  • Authorized Prescribers — List of approved individuals.
  • Signatures — PI, IRB Chair, R&D Committee Chair.

Step-by-Step Process for Using VA Form 10-9012

  1. Complete the form as the PI with accurate drug information.
  2. Submit to Research Pharmacy for review before first dispensing.
  3. Obtain approvals from IRB and R&D Committee.
  4. Place in patient record — The PI must ensure a copy (or electronic equivalent) is placed in the subject’s VA medical record.
  5. Update as needed — Provide revised copies for changes in prescribers, protocol, or drug info.
  6. Pharmacy integration — Used alongside VA Form 10-1086 (Research Consent) for dispensing.

Why VA Form 10-9012 Matters for Veteran Research?

VA research protects Veterans while advancing medical knowledge. This form helps minimize risks by ensuring all clinical staff have quick access to critical safety data. It supports proper inventory control, accountability, and emergency response in VA facilities nationwide.

Compliance with this and related policies (like VHA Directive 1200.05) is mandatory for studies involving investigational drugs.

Official Download Link:
Download VA Form 10-9012: Investigational Drug Information Record

For the most current guidance, always check official VA websites or consult your local VA facility’s Research Service. This form remains a cornerstone of safe and ethical VA clinical research involving medications.