Recently I had the pleasure to attend GCP meeting in London, UK where there was a discussion on common audit findings in clinical trials. Some of the issues discussed are not new and still it seems majority of the hospital teams fail to act to avoid them.
What are the common issues during inspections?
1) Inadequate source data: Missing source data or discrepancies between electronic medical records (EMR) and paper sources are quite common issues.
How to fix – Develop a checklist to make sure you capture all relevant information during each visit. Make sure paper and electronic source are consistent and if there are discrepancies address them as soon as possible.
2) Printing electronic source for monitoring/auditing/inspection: Often the documents printed from EMR are not reviewed and confirmed as correct.
How to fix – Every printed document needs to be reviewed and confirmed from quality assurance team as true with the original, signed and date.
3) Transcription inaccuracy into the CRF: Discrepancies between data in the CRF and source data are quite common.
How to fix – Check what you have entered into the CRF before jumping to the next page!
4) Informed consent process: Inadequate source documents to confirm the consent process is another quite common issue.
How to fix – Document clearly in the notes what was discussed with the patient and any question from the patient. It is important to know who had discussion with the patient and if they were given time to consider their participation.
5) Lack of PI oversee: Unfortunately often this is a significant issue for some hospitals. Sometimes the issue is not with “lack of PI oversee” but lack of documentation that PI is overseeing the study.
How to fix – Make sure you document all meetings with PI and discussions in meeting minutes; file e-mail correspondence regarding study specific issues and decisions discussed with the PI; make sure PI has access to CRF, IVRS and other relevant study systems.
6) Inadequate number of staff working on the study: This is another serious challenge in clinical research. It is quite common studies to be run by only 1 nurse or sub-Investigator.
How to fix – This is a difficult one but always consider the available resources before committing to more studies. Make sure your team always has a backup.
7) Study drug temperature monitoring: Temperature monitoring is often an issue especially in clinical trials with refrigerated drugs.
How to fix – Often temperature monitoring does not stop with pharmacy! Make sure you monitor the temperature if you keep refrigerated drugs in a department fridge after dispensing and before administration.
8) Delegation of trial related duties: It is common that nurses or registrars who are temporary covering for the study are not listed on the delegation of authority log.
How to fix – Make sure there is a study trained person to cover you when going on leave. If no one is available, make sure the person that will cover is adequately trained and on delegation log before performing any study related duties.
9) Lack of evidence of GCP training: Missing GCP training certificates or other related documentation.
How to fix – Make sure you keep all GCP certificates electronically and GCP training is documented in CVs.
10) Calibration of equipment: Equipment calibration is often ignored issue in clinical trials because the team presumes it is done. However, equipment used in clinical trials will need to have adequate calibration documents.
How to fix – Keep copies of equipment calibration documents in the research office and make sure you have the most up to date documents.
11) Untimely review of lab results: The date of investigator signature on the lab reports is important. Even if they have reviewed them as soon as they are available the signature and date are important proof that this was done.
How to fix – Prepare workaround procedure to guarantee the lab reports are no only reviewed electronically but also signed and dated. You cannot proof they have been reviewed if signature and date are missing. Another important part is abnormal lab ranges to be assessed if they are clinically significant.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 3 June 2016