The sponsor discontinued the clinical development of an investigational product. In accordance with the ICH GCP Guidance, at least how long should…

The International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6(R2) guideline provides specific instructions for record retention. Section 5.5.11 states that sponsor-specific essential documents should be retained for "at least 2 years... since the formal discontinuation of clinical development of the investigational product." This requirement ensures that trial data and conduct can be reviewed and verified for a reasonable period even if the product does not advance to the marketing stage. The period begins from the date the sponsor formally decides and documents the end of the product's development program.

B. 3 years: This is not the minimum retention period specified by ICH GCP for a discontinued investigational product.

C. 5 years: This duration is not stipulated by ICH GCP for this specific scenario of product discontinuation.

D. 15 years: While some national regulations (e.g., US FDA 21 CFR 312.57(c) for INDs) may imply longer periods, the specific ICH GCP minimum for a discontinued product is 2 years.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2016). Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Section 5.5.11, Record Retention.

2. University of Rochester Medical Center, Office for Human Subject Protection. (n.d.). Investigator Guidance: Data and Safety Records Retention. Section: ICH E6 Good Clinical Practice. Retrieved from the University of Rochester Medical Center website. (This document explicitly states, "ICH E6 requires that sponsor-specific essential documents be retained for at least 2 years after formal discontinuation of the investigational product.")

3. Krishnankutty, B., Bellary, S., & Kumar, N. B. R. (2012). Data management in clinical research: An overview. Indian Journal of Pharmacology, 44(2), 168–172. https://doi.org/10.4103/0253-7613.93842 (This article discusses the principles of data management and archiving in line with GCP, referencing the standard retention periods outlined in guidelines like ICH GCP.)