Hi, I'd be very grateful for thoughts/advice on the following Consent Form questions please:

  • Should the Consent Form include the trial number/Patient ID? This is usually not known until after patient registration and after the Consent Forms have been signed; copied and distributed; including a copy to the patient. It also relies on the site going back to the original and adding the trial number. Is this an issue as the original does now not match any copies. Some of our trials donít include it for the reason of not wanting to amend post signing and it has often been a finding at monitoring visits that site staff have forgotten to go back and add it; but other trials say it is useful for example to reconcile against samples which are sent to a biobank along with a copy of the Consent Form; as the samples are identified by trial number only?
  • Is it good practice to document time of consent in the source (and therefore capture it on the Consent Form)? Unless there are very time specific screening activities and we are collecting time of procedures on the CRF; Iím not clear if this is necessary.
  • We are also reviewing our Consent Forms to ensure we are appropriately consenting for long term data retention/sharing and future storage of samples which are gifted by the patients; i.e. either in a biobank or for possible future use in other research beyond the REC approval. Is there any guidance on wording for such sections of the Consent Form available?
  • As long as there is an agreed process in place; including transfer; checking and storage (if required) of the Consent Form; are there any issues/considerations for asking sites to provide copies of the Consent Form to the trials office?