|
|
|
|
|
 |
|
Maureen Hurst
Research Subject Advocate
12 South, Univ Hospital,
Rm 071,
Stony Brook, NY 11794-7124
Phone: 631-444-7759
Fax: 631-444-6930
Email: Maureen.Hurst@Stonybrook.edu |
- Conducting a review of clinical trial study documentation including but not limited to making certain that adverse events are reported, protocol amendments are filed with the IRB, inclusion/exclusion criteria is followed, # of patient visits and specimen collections do not exceed the protocol guidelines
- Continually reassessing each protocol to ensure subject safety
- Ensure that the IRB- and GAC-approved monitoring plan is fully implemented and that the protocol carried out at the GCRC complies with the IRB- and GAC-approved protocol.
- Ensure that GCRC investigators send expedited adverse event (AE) reports in a timely fashion to the IRB, GCRC and appropriate Federal agencies.
- Help investigators come into compliance with the requirements.
- Perform audits as requested and at random.
- Ensure the GCRC application includes the appropriately completed human subjects section, especially inclusion of women, children and minorities and Data and Safety Monitoring Plans and Data Safety Monitoring Boards if required.
- Ensure the GCRC application includes a proposed or approved consent form and that the consent form accurately describes the proposed research.
- Remind Principal Investigators and study coordinators of expiration dates (consent and protocol) in order to ensure that research is conducted in the GCRC only on current, approved protocols.
- Observe the consent process and educate investigators and study coordinators on the requirements for informed consent.
- Assist patients or staff with the resolution of any patient or staff generated questions regarding participation of human subjects in studies.
- Educate PI's and Study Coordinator's on proper GCP's and regulations.
|
|
