According to a study by the Tufts Center for the Study of Drug Development, almost 60 percent of clinical trial protocols for new drugs are amended at least once.
The first step with any amendment is to understand what changes are being made, and how they will affect the research. Is there new safety information that needs to be reflected in the consent form? The revisions will have to be accepted by both the sponsor and the IRB/EC. What about new procedures? Updates to the clinical trial billing plan, contract or budget may be necessary, and data collection procedures will need to be revised and possibly re-validated.
The next step is to submit the amendment documents for approval. If the InfoEd clinical trial record is linked to a protocol in the Human Subjects module, this will mean creating a new amendment submission, attaching the relevant documentation and possibly filling out an amendment form, if that is part of the institution’s submission process. The submission is then routed electronically to the IRB. If the IRB needs to request additional information or revisions, that process is also handled electronically and documented within the system. Upon approval, when the IRB office updates the protocol, the linked information is pushed automatically to the clinical trial record, along with the associated notification letter and approved documents.
Amendments often require some degree of re-training for the research team. At the very least, everyone needs to be informed when changes are made to the protocol or to the way the trial is being conducted. The built-in communication tools make it easy to distribute updates and document what information was shared, when and with whom. Relevant information can also be forwarded to ancillary functional areas such as the research pharmacy or budget office. Face-to-face training sessions or meetings can be set up via the trial calendar, with invitations that include an option to add the event to the respondent’s external calendar.
Re-consenting may also be required for some or all previously enrolled subjects. The system provides several different options for tracking and reporting on re-consenting. Copies of signed consent forms can be stored in the various participant records and in the virtual regulatory binder for the trial.
Tracking all of these activities within the InfoEd system helps to ensure all essential steps are completed, in a manner that maintains regulatory and ethical compliance.