FDA updates CRO & sponsor inspection guidance

By Nick Taylor

- Last updated on GMT

The FDA has revised guidance on how its personnel conduct inspections of CROs and sponsors in light of technological advances.

Guidance on the topic was first issued in 2001 but since then clinical research and outsourcing have evolved. Revisions to the document cover industry shifts and technological advances, such as the rise of electronic records, but the focus and goals of the document remain unchanged.

These regulations establish specific responsibilities of sponsors for ensuring the proper conduct of clinical studies for submission to FDA (US Food and Drug Administration) and the protection of the rights and welfare of subjects involved in clinical studies​”, says the guidance.

While retaining this focus the FDA compliance program guidance manual (CPGM) for sponsors, contract research organisations (CRO), and monitors​ has been revised with the addition of new sections and deletion of others.

For instance, electronic records and signatures are now covered by the guidance. Although this is new the goal is unchanged, with regulatory requirements staying the same “whether clinical data are captured on paper, electronically, or using a hybrid approach​”.

Submission of information to ClinicalTrials.gov is another change. Inspectors must now determine if studies were registered on ClinicalTrials.gov, who entered the information, and whether primary and secondary outcome measures are listed.

Global regulation

Clinical trials are increasingly conducted outside the US and the FDA guidance accounts for this change. Overseas trials must be compliant with good clinical practice (GCP), says the guidance, and the FDA must be able to validate data through an on-site inspection if deemed necessary.

Globalisation has advanced alongside multisite trials and both are addressed by the guidance. “With the prevalence of multisite clinical trials, traditional monitoring techniques – early and frequent on-site visits at all clinical sites – have become resource intensive​”, says the guidance.

Other areas addressed by the guidance include: what to do when fraud is suspected; financial disclosure from investigators; and how to investigate whether emergency research followed guidelines.

Related news

Show more

Related products

show more

VDS groß

Meet the challenges of complex injectables

Vetter Pharma International GmbH | 07-Nov-2017 | Technical / White Paper

In the time it takes from the exciting discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can...


Process Development for Lyophilized Products

Baxter BioPharma Solutions | 30-Oct-2017 | Application Note

Baxter approaches formulation and process development with the intention of identifying the failure points for the product. Knowing where the product fails...


Advancing therapeutics for myeloma

Recipharm AB | 04-Sep-2017 | Case Study

Multiple myeloma is the second most common blood cancer in the world and despite survival rates increasing over the last decade, there remains a requirement...

Related suppliers