Re-Consent

*The timeline requirements for this form are as follows:
Assessment Time Frame: At the time of re-consent
Submission Time Frame: Within 10 business days of re-consent and/or re-assent.

Re-consents are logged on a common form, which is available at the bottom of the subject’s page in EDC. Click +New to log a new event. The maximum number of new events which can be added is 100.

If new information becomes available that affect a subject’s rights or welfare, that information shall be provided to the affected subject(s) in written form via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date an addendum to the ICF. The IRB will determine the method and the subject population to be re-consented.

Other situations may necessitate revision of the ICF, such as amendments to the study protocol, a change in site PI, or following annual review by the IRB. The new version of the ICF must be approved by the IRB. The IRB will determine the subject population to be re-consented.

Reason for re-consent:
Indicate the reason for re-consent from the following options:

• Required by IRB
• Other
  

If Other is reported, provide reason below.

Specify reason:
This field will only appear in the EDC if “Reason for re-consent” is answered Other. Provide description of other reason for re-consent in this free textbox (up to 200 characters).

Date study ICF signed:
Report the date the new Informed Consent to Participate in Research Study for the study was signed by the subject or legally authorized representative. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.

If the date entered is a future date, a query will appear in the EDC.

Study ICF version:
Report which version of the Informed Consent to Participate in Research Study was used to obtain subject or legally authorized representative consent. Indicate the version number and/or version date (up to 100 characters).

Study ICF language:
Report language of the Informed Consent to Participate in Research Study used to obtain subject or legally authorized representative consent. If a short form was used, report the language, and indicate “short form.” For example, “Spanish short form.” (up to 100 characters).

Protocol Version:
Select the protocol version the subject was re-consented to from the dropdown list.

If the correct protocol version is not available for selection, contact the study inbox at ACCELERATE@nmdp.org for assistance.

*Add additional forms as needed. This form can be repeated up to 100 times.

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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.