Consent is a major phase of the trial enrollment process: it is submitted to strict legal constraints, which vary from country to country. Additionally (or consequently?), it is still often paper-based, which makes it logistically complex.
No wonder it took months for the Allyfe team to finetune a modular and safe consent module, given the numerous configurations and formats it must take on to fit the needs of all sponsors and investigators. Particularly since it also needs to maintain a user-friendly, flexible and intuitive interface for trial professionals who manage the procedure…. Trying to square the circle, you said?
This is the result of their cogitations:
Informed consent forms (ICF) can have three different formats on the Allyfe platform. What the formats have in common is that they all can be easily viewed by the patients at their convenience before they are allowed to sign them. They are all searchable, electronicallystored and traceable.
The first format is the fully digital setup. The investigator can set it up from scratch and create each section of the ICF, including mandatory and optional consent(s) for each trial population. The platform will generate a pdf document with fillable sections for each variation of the ICF. This option is ideal when the ICF needs to be translated into different languages, for instance. It can be signed electronically by the patient and by the investigator.
The second format is the static pdf. It is ideal for wet ink signatures. The investigator uploads an ICF in pdf format onto the platform. The patient and the investigator can print the consent form and sign it in person. The investigator will scan the document and upload it on the platform. It is included in each individual patient record. With this ICF version, the investigator has to add mandatory and optional consents selected by each patient manually on the platform.
The third format is halfway between the static pdf and the fully digital set up. It is the fillable pdf. This format is ideal when the investigator has a pdf version of the ICF including fillable sections. The investigator has to upload the document onto the platform and name the different fillable fields (such as the optional consents, for instance, which will be automatically added to the patient’s profile on the platform). The patient and the investigator can sign the form electronically on a PC, tablet or mobile phone, remotely or during a physical meeting.
Finally, let’s not underestimate the crucial importance of reconsent modalities for clinical trials. The Allyfe team has already integrated the possibility of reconsent into the trial setting. The purpose is to accelerate a procedure which often slows down the whole trial process. Accordingly, the sponsor can use the platform’s appropriate communication channels to inform research sites of the need to obtain reconsent, and simultaneously share the new ICF with them. Investigators can then select targeted populations using the filters at their disposal on the platform. Notifications are automatically sent to the patients concerned, informing
them of the need to repeat the consent procedure they are already familiar with. Reconsent is obtained and stored electronically just like original consent.
How does the ICF setup functionality benefit…..
…..the patient? Whatever the chosen format is, the patient can view it at his convenience, list the questions and concerns he has and ask accurate questions during the conversation he will have with the investigator about it . Since his optional consents are added to his profile, he can easily modify at any point during the enrollment procedure. Again, the patient is considered here as a full-fledged partner of the trial, which enhances his/her motivation and engagement.
….the investigator? The investigator can select the format which best fits his/her national regulations, trial format and linguistic needs. He/she can then easily assign different ICFs to different populations and store them electronically, allowing an audit trail of different time-stamped versions. Additionally, he can view all patients’ decisions on optional consents. Potential reconsent procedures are just as smooth and efficient.
….the sponsor? The sponsor has at his disposal a full and updated list of all the variations of the master ICF he issued for every clinical trial. If need be, the sponsor can trigger reconsent procedures quickly and simultaneously for all research sites.
….the CRO? The CRO can propose a compliant and flexible tool for any (re)consent procedure research sites have to apply.