Should record notes be signed in clinical trials?

07 January 2014

Pursuant to section 5 of the Danish executive order no. 3 of 2 March 2013 on authorised healthcare professionals’ patient records (record keeping, storage, dissemination and transfer etc.) (in Danish) authorised health professionals who offer patient treatment as part of their activities are under an obligation to keep patient records.

It appears from section 10 of the executive order that prescription of medicines (also in connection with clinical trials) as part of the treatment must be recorded, including the name of the prescribing healthcare professional.

The authorised healthcare professional is responsible for the contents of his or her own notes in the patient records. At hospitals and clinics using cross-functional patient records or clinics comprised by the Danish act on company-responsible physicians, the healthcare professional is not required to verify the records when using dictation, cf. section 7 of the executive order.

The general record keeping rules in the executive order on authorised healthcare professionals’ patient records are supplemented by the Danish executive order on good clinical practice in clinical trials of medicinal products in humans (the Danish GCP executive order: Danish executive order no. 695 of 12 June 2013 on good clinical practice in clinical trials of medicinal products in humans) (in Danish).

Regarding records in connection with clinical trials, stricter guidelines apply: Guideline for Good Clinical Practice ICH E6 (CPMP/ICH/135/95)). It appears from one of the main principles (2.10) that all clinical trial information, including data, should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification.

In addition, items 4.9.1 and 4.9.2 indicate that the investigator should ensure the accuracy, completeness, legibility and timeliness of the data reported to the sponsor and that the data reported should be consistent with the source documents. Consequently, it has been laid down in the Danish GCP executive order, issued in accordance with the Danish Medicines Act, that “the investigator should ensure that source data as well as registered data are accurate, complete, legible and timely” (section 9(1)).

This means that the record notes made in connection with clinical trials, containing source data and made after the ’informed consent’ has been obtained, must be verified by the authorised healthcare professional (investigator, project nurse etc.) who is responsible for the records. The verification must be documented.

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