Amendments

A request to amend an RDRC-approved protocol should be submitted to the RDRC under the following circumstances.

1. All modifications of protocols approved under the authority of 21 CFR 361.1.
2. Modification of other protocol types that relate directly or indirectly to the use of the radioactive drug(s) in this study. Such changes include, but are not limited to, change in the dosage of radioactive drug(s), change in the number of radioactive drug administrations, inclusion of a new radioactive drug in study, other changes in protocol that will increase radiation exposure, increase in the number of subjects who will receive radioactive drugs (or other changes in the subject population), and change or departure of the responsible physician.

All amendments meeting the above criteria must be reviewed and approved by the RDRC. Note that the RDRC is notified by HRPO of all modifications for studies involving radioactive drugs.

A request to amend an RDRC protocol should include the following:

1. A cover letter describing the nature and rationale for the amendment
2. A revised RDRC application, including revised dosimetry tables, where applicable.
3. A revised protocol.
4. Revised consent form(s)
5. The MyIRB modification form.

Include clean and tracked changes versions of all of the above, where applicable.

Please submit electronic copies of the individual amendment documents to rdrc@wust.edu.