Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3
From GxPlex
| Document information | |
|---|---|
| Reference | EU EMA/INS/GCP/112288/2023
- Guideline on computerised systems and electronic data in clinical trials 2023 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/INS/GCP/112288/2023
- Guideline on computerised systems and electronic data in clinical trials |
| Version / Revision | 2023 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/INS/GCP/112288/2023
Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on computerised systems and electronic data in clinical trials |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 â Unit 3.1.1 |
| Scope | G |
| Document part | Annex A
A5.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Informed consent, Electronic signature, Ethics committee, Consent process, Good clinical practice |
| Comment | Electronic informed consent: ethics committee review |
Content
A5.3 Electronic informed consent Ethics committees will review all material related to the informed consent process. Before the implementation of an electronic consent procedure is considered, the sponsor should ensure that the electronic consent procedure is GCP compliant and legally acceptable in accordance with the requirements of the independent ethics committees concerned and of the national regulatory authorities.
The principles of consent as set out in legislation and guidance should be the same regardless of whether the process involves a computerised system. A hybrid approach could be considered, where national requirements preclude cern parts of an electronic informed consent procedure. At present, in some countries failure to provide 'written on paper' proof of a trial participantâs informed consent is considered a legal offense.
An electronic informed consent refers to the use of any digital media (e.g. text, graphics, audio, video, podcasts or websites) firstly to convey information related to the clinical trial to the trial participant and secondly to document informed consent via an electronic device (e.g. mobile phones, tablets or computers). The electronic informed consent process involves electronic provision of information, the procedure for providing the opportunity to inquire about details of the clinical trial including the answering of questions and/or electronic signing of informed consent. For example, it would be possible for the trial participant to sign informed consent on a paper form following provision of the information electronically or the information and informed consent could be entirely electronic. If using a âwet inkâ signature together with an electronic informed consent document (a hybrid approach), the patient information, the informed consent document and the signature should be indisputably linked.
The method of obtaining an informed consent should ensure the broadest possible access to clinical trials. Alternative methods for provision of information and documentation of informed consent should be available for those unable or unwilling to use electronic methods. Any sole use of electronic informed consent should be justified and described in the protocol. [...]
