Archiving essential trial documents access to medical records

Archiving of essential trial documents

Are you conducting the trial in accordance with good clinical practice? Then you must save all essential documents of the trial. These documents can be paper, electronic or digitised documents.

The EMA-document “Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)” describes in more detail the criteria regarding archiving of essential trial documents. More specific, chapter 5 of this guideline gives guidance regarding scanning of documents and the use of certified copies. For more information, see:

• 1.23, 1.51, 1.52, 1.63 and Chapter 8 of the ICH-GCP guideline (CPMP/ICH/135/95);
• article 20 of the Directive 2005/28/EG. 
• Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic), 06 December 2018, EMA/INS/GCP/856758/2018, Good Clinical Practice Inspectors Working Group (GCP IWG).

Access to the medical records of trial subjects by others

A trial subject must agree to inspection of all his/her medical records by several parties. This concerns, for example, the committee that monitors the safety of the trial, a monitor who works for or is hired by the investigator/commissioning party of the trial, or national and international supervisory authorities (such as the Health and Youth Care Inspectorate). This consent must appear in the information for trial subjects and in the consent form that a trial subject (or his/her legal representative) signs.

These parties may do this to monitor and verify research procedures and/or data. In this way, these parties can examine/verify the reliability, traceability and accuracy of the data from included test subjects which are relevant for the clinical trial.

For more information, see:

• articles 4.8.10 n, 5.1.2, 5.15.2 and 8.3.12 of the ICH-GCP guidelines;
• the government brochure 'Medical research' which is written in Dutch;
• the CCMO website.