Transcelerate Econsent Site Frequently Asked Questions Template

TransCelerate eConsent
Site Frequently Asked Questions Template

Purpose of Document:The contents of this document were developed as outputs from eConsent site advocacy group (SAG) meetingscommissioned by TransCelerate through the Society for Clinical Research Sites (SCRS). The suggested FAQs and responses are based on hypothetical circumstances and are intended merely to give those sponsors and vendors using eConsent some idea about the types of questions that may be raised by sites and examples of hypothetical responses.

Note: The responses (and perhaps the questions as well) will need to be substantially revised to tailor them to the relevant circumstances. These FAQs and responses are provided purely for illustrative purposes and are intended to provide neither specific language nor actual substantive responses to use in responding to a site’s questions. Specific system requirements, local conditions, and other factors may affect how a sponsor or vendor might respond to these illustrative FAQs.

Question / Response
Privacy and Data Handling
What study participant information is captured in eConsent? / The study participant’s first and last names are captured in the eConsent system. The name is entered into the system and the study participant’s signature is retained.This information is accessible by monitor and site staff.
How is access controlled to protect study participant’s privacy? / The vendor controls the individual user permissions based on what information each user is allowed to see. CRAs and site staff can see all study participant information while the sponsor would only be able to see study participant code and date ICF(s) were signed.
Can the vendor access study participant’sidentifying information? / This would happen in rare situations. The vendor has very specific rules for any of their staff to be able to access the information. Access is only allowed under extreme circumstances by limited vendor staff trained in appropriate privacy laws.
Is any information stored on the device, or is it stored on a remote server? / No information is stored on the iPad/tablet. The data is stored on external servers.
Will the data be obtained, transferred, treated, and stored in a manner that protects privacy and complies with data storage/transfer requirements? / <Insert vendor’s data privacy plan here>
Is the eConsent system validated, as system for storing study eConsent data information? / Yes
What protections exist for personally identifiable information? / Data is encrypted and access is role based.
What is considered the source data in an electronic system? / The Electronic is the source data but as with other electronic data (e.g.,eCOA data printed PDF’s are considered certified copies of the data. (Country specific whether paper or electronic is the source document)
What is considered the source data in a “print to sign” – local requirements to sign paper document after multimedia ICF review / The paper is the source, but the monitor may also be advised to review both systems. It is advised to check local requirements.
Operational Considerations
Can the vendor accommodate regulations in the various countries, e.g. privacy regulations, additional required witness signatures, etc.? / Yes, the vendor tools are very flexible and can accommodate changes at the site level.
How experienced is the vendor in working with IRB/IECs? / eConsent Vendor has launched eConsent in a number of global studies and has worked to develop relationships with health authorities/regulatory agencies and IRB/IECs.
Can aneCOA/ePRO device be combined with the eConsent? / Several vendors have developed a way to combine eCOA/ePRO tablets and eConsent onto a single device. Therefore, the site can access the eICF using the same tablet.
Will the training be provided in a variety of languages? / Currently, training at the Investigator Meeting and online is conducted in English. If translation of the training is needed, please let your sponsor contact know.
Is there support from the vendor in local languages to train sites or to get technical support if needed? / Yes, the help desk is set-up in the different regions to ensure the site has access to local language support.
What time zone is used to apply the time stamp in the audit trail for the consenting process? / The local time zone is the standard view in the vendor audit trail.
How long is the study eConsent stored on the vendor servers? / The data will be stored on the active server for approximately one year after the end of the study. Each site will receive a site-specific download of information for long term storage. The study eConsent data is stored in archived servers should the data need to be accessed in the future. The length of archive storage varied by country based on regulatory requirements and contractual obligations.
Will the signed consent forms still need to be printed and filed in the physical site binder or can they now be stored electronically? / If the site SOP’s allow for ICF’s to be stored electronically, they do not need to be printed and filed in a physical site binder. All signed ICF’s will need to be readily available and easily accessible in case of site audit or monitoring visits.
How will amendments to the eConsent be handled and pushed to the sites? Will it cause downtime in the usability of the system? / The vendor will work to limit any downtime in the functionality of the eConsent system due to amendments.
If I have a patient waiting to consent and the system goes down what should I do? / If the system goes down, the first suggestion would be to contact the help desk. If a patient is waiting and the help desk can’t assist with a quick resolution, resort to using a back-up paper method of consenting.
How can I at the site be assured I’m using the most recent version of the consent? / Only the most recently approved version is available for use by the site. The system may also have a version date that can be referenced and compared with approval date.
Translations – how does PI ensure that translations are approved, and how do they know they’re using the right translations (for countries that have many languages)? / To ensure that a translation is approved, a certificate of translation and an approval letter should be provided (depending on local requirements). To ensure the correct translation is used, the system should identify what language the translation is.
How would you manage illiteracy? / Electronic systems do offer the potential to present study information in alternative ways (e.g., video, audio). However, traditional methods are also suggested, including the use of a legally authorized representative.
Patient Use
Does the eConsent have to be viewed on the tablet at the site, or can the study participant take the tablet home to review? / The eConsent currently needs to be viewed on a tablet at the site. However, a printed copy or link to the consent can be provided to the patient for them to take home and review.
Some Systems offer the ability to view parts of the consent materials via web browser so subjects can view at home.
Will the study participant receive a signed copy of the eConsent? / Yes. The site staff can print wirelessly from the device if they have a wireless printer, or they can print a copy from their computers via a dashboard.
Are the patients provided with training? / Patients are not provided with specific training on the device. The site staff should ensure the patient knows how to use the eConsent prior to providing to the patient.
If subject signs paper, will/can they sign electronic version later? (or switching back and forth from paper to eConsent) Can they mix paper and electronic? / Yes, the eConsent system allows for switching between paper and electronic signatures.
Will subjects sign eConsent at the site or can they sign at their home? / eConsent usually needs to be signed at sites. This allows patients to obtain answers to any questions and make sure patients understand clearly.Some sponsors may support remote signature. A site explores with the sponsor whether this is an approach the sponsor may beconsidering.
Trouble Shooting
What should we do if the eConsent data is not saved into the system because of errors? Should we re-take whole consent process again? / It is recommended to confirm whether data is saved at during the consent process. If any issues occur, contact help desk or sponsor.