It is vital that all participants who are recruited into a clinical trial, sign consent before any trial related procedures occur.
In line with GCP and ICH guidelines, the participants must be given a patient information sheet detailing the study which must be introduced and discussed with a GCP qualified person, usually the doctor in charge of the participant or a research nurse. This must also include informing the participant of any pain implications or about possible risks or side effects as well as discussing any possible alternative treatment. The participant must have ample time to consider the study and should be advised to talk it through with members of their family. Once they have had time to answer any questions then with the GCP delegated person the consent form can be signed.
The original consent form must be filed in the Investigator Site File together with a copy of the patient information sheet in recruitment order, with a copy for the participant and a copy in the participant’s medical records.
This process needs to be clearly documented in the medical records including the full study title (avoiding the sole use of acronyms).
- Voluntary agreement to participate in the clinical trial
- Refusing to participate or discontinuation will have no penalty
- A clear box with patients allocated trial number
- The possible consequences of withdrawal
- Acknowledgement of the information that has been provided and all patient’s questions have been answered
- A clear guidance of patient confidentiality and data collection
- The patient’s legal representative agreement that the sponsor’s representatives, regulatory authorities and REC will be given access to the patient medical records
- In line with the Human Tissue Act, details of any tissue taken will be anonymised and stored appropriately.
In cases where the participant is unable to read or write or speaks another language, then a witness should be available to ensure that the participant has been informed and has had time to consider the study and ask questions. As well as the participant or the legal representative the witness should also sign and date the consent form to confirm that the information was accurately explained and that the informed consent was given.