MSB Docs lets you digitize the way you provide subjects with the information they need to decide to volunteer for a research study. Going digital with us will let you keep up with all the key information elements intact as well as the consent requirements that are set forth in FDA’s regulations on Protection of Human Subjects.
A statement that the project is research and participation is voluntary
A summary of the research, including:
Reasonable, foreseeable risks or discomforts.
Reasonable, expected benefits
Alternative procedure or course of treatment, if any
Consent Process Diagram
Initial Consent
Consent Form
New Risk Information
Change in Research e.g., Procedures, Visits
Loss or Gain of Subject Capacity to Consent
Study Extention
Change in Drug Status e.g. Approval, Withdrawal from Market
End of Study
Long Term
Follow-up e.g., Lifetime for Gene Transfer or Cancer Studies
Various amendments and approvals, when done using paper-based processes increases the cost, time and efforts of the entire team.
Avail consent from the subject at various stages using electronic signatures.
Make as many amendments as required on the documents.
Easy sync of the updated document in the cloud repository
Include appropriate signature and date lines for consent as applicable.
Keep track of records with Audit Trail for each document
Set alerts to notify the subject about the changes and required signatures