Ongoing Review

Subject Transfers

During a research study, it may be necessary or desirable for subjects participating at one research site to transfer to another research site. This may be because the first site is discontinuing its research program, the subject is permanently or temporarily moving out of the area, or for other reasons.

Subject transfers do not require Board approval, but Schulman requires notification of subject transfers to help ensure that the subjects’ rights and welfare are protected throughout the transfer process. Both the site transferring the subjects and the site receiving the subjects should notify Schulman of subject transfers via the next Study Status Report Form.

At the initial site, the transferring subjects and the Sponsor/CRO should agree to the transfer, and subjects should sign an Authorization to Use and/or Disclose Protected Health Information (US) or a Personal Information Protection and Electronic Documents Act or PIPEDA document (CAN) so that study records may be sent to the new site. At the new site, subjects should receive an introduction to the site from a Research Coordinator or the Principal Investigator (PI) /Qualified Investigator (QI) and should be presented with the new site’s current site-specific Informed Consent (IC) and HIPAA Privacy Authorization (US) or PIPEDA document (CAN). If the compensation for participation differs at the new site, this should be discussed with the subject. The subject has the right to decline to continue participation at the site because of a difference in compensation, or for any other reason. If there are any questions regarding this process you may contact Ongoing Review Services via e-mail.