Statement of Practice: Approval Dates on Consent Documents & Recruitment Materials - ARCHIVED

For new applications that are approved with contingencies, study activities may not begin until all outstanding contingencies have been met and verified with the IRBMED. At that time, consent documents and recruitment materials will be watermarked (when possible) with the “Approved with Contingencies” date.

For Scheduled Continuing Review or Amendment applications approved with contingencies, study team members should continuing utilizing the most recently approved consent documents and recruitment materials until all contingencies are cleared and new/updated documents and materials are issued under “Approved Documents.” At that time, consent documents and recruitment materials will be watermarked (when possible) with the “Approved with Contingencies” date.