Investigational Product Management Flashcards

Good Manufacturing Practice (GMP) requirements for investigational products are primarily intended to ensure:

Answer: Product quality, identity, purity, and potency for subject safety and reliable trial results

GMP for investigational products (21 CFR Part 211 in the US) ensures that manufacturing processes produce consistent, safe, and accurately labeled product that supports both subject safety and data integrity.

What information must appear on investigational product labels per GCP and regulatory requirements?

Answer: Trial number, protocol ID, subject/dose information, storage conditions, sponsor contact, and the statement 'For Clinical Trial Use Only'

GCP IP labels must include the clinical trial identification, dosing information, storage requirements, sponsor or manufacturer contact, and the mandatory statement that the product is for investigational use only.

Subject medication compliance (adherence) is most commonly assessed in clinical trials by:

Answer: Pill/device counts, subject diaries, or plasma drug level measurements

Compliance is typically measured through returned pill counts, patient diary records of doses taken, and/or pharmacokinetic sampling to confirm drug exposure, as specified in the protocol.

If a site's pharmacy refrigerator storing investigational product fails overnight, the CRA should advise the site to:

Answer: Document the excursion details (temperature range, duration) and contact the sponsor's clinical supply team for disposition guidance before dispensing affected product

Temperature excursions must be fully documented and assessed by the sponsor's supply and quality teams before any affected product is used; dispensing compromised IP could harm subjects.

An IP 'expiry date extension' means:

Answer: The sponsor has performed additional stability testing and obtained regulatory approval to extend the product's use-by date

Expiry extensions require new stability data demonstrating the product remains within specifications, followed by updated labeling and regulatory notification where required.

What is the purpose of a 'double-blind dummy' (matching placebo or active control) in a clinical trial?

Answer: To maintain blinding by ensuring all treatment arms have identical appearance, so neither subjects nor site staff can distinguish active from placebo

Matching placebos or dummy controls are formulated to be identical in appearance, taste, and texture to the active product, preserving blinding integrity throughout the trial.