Clínica Optimus U – Clinical Research


Common Inspection & Audit Trends

In this issue we would like to discuss the common GCP audit findings. These are consistent with FDA inspection observations of clinical sites collected from FDA Form 483 (FDA Bioresearch Monitor- ing (BIMO) Fiscal Year 2020 Metrics).

  • Source documentation: inadequate and/or inaccurate case history records; inadequate study records
  • Informed consent issues; inadequate subject protection
  • Lack of investigator oversight of clinical study conduct including inadequate delegation of task and insufficient training
  • Protocol adherence issues: failure to follow the protocol resulting in protocol deviations
  • Drug accountability

To ensure participant’s safety and data integrity as well as to promote better compliance, we will present these GCP audit findings with suggestions to help your site be audit/inspection ready at all times.


Audit Finding: Source data was not attributable, no con- temporaneous handwritten updates/entries made to Electronic Medical Record (EMR) data printouts, source templates and other participant’s documentation not signed and dated to indicate who made the entries and when the entries were written.

According to ICH E6 (R2) 4.9.0, the investigator/institution should maintain adequate and accurate source documents and trial rec- ords that include all pertinent observations on each of the site’s study participants in adherence to the ALCOA-C Principles.

INFORMED CONSENT – Specimens Collected Prior to Consent

Audit Finding: Research samples taken with- out/prior to participant consent.

Not only is this a serious breach of GCP but it also constitutes a breach of privacy which may require additional reporting to state/provincial privacy boards or the sample owners.

We recommend more proactive approaches as consenting reminders, such as using a log, affixing brightly colored stickers to participant source binders, or setting up electronic flags in the EMR and/or eSource Data System. If a similar deviation occurs at your site, re- member to notify the lab to destroy the sam- ple, check provincial/ state regulations for re- porting requirements, and notify both the ethics board and your monitor.

Trial Product Returns

Study participants may not be able to visit your site due to COVID. We recommend to take the following steps:

  • Check their trial product in-use time and expiry date before each
  • Keep all trial products that is expired or has been used up in a separate container from unused trial
  • Do not dispose of any used or unused trial product; it must eventually be returned to your site, unless the protocol specifies
  • If approved by your study team, study participants may return used/partly used/unused trial product by courier (North America Clinical Operations COVID- 19 Site Update #6 is attached for further details).

Please remember to document in participant’s source document if an alternative method is used.