|
Your First Application to the GCRC
|
|
After Your Study Has Been Approved
The next steps in getting your study started after you have received approval to conduct your
trial on the GCRC are to:
Meet with our Nurse Manager
Discuss:
- The specifics of the services you will need
- Any specialized supplies or nursing procedures you will need
- How to draft your study orders
- Any other issues related to your protocol
Review GCRC policies and let us know if you have any questions.
Set up an AAA account (if necessary)
An AAA account may be necessary for research billing for services not provided by the GCRC.
For information on setting up a AAA account, registering your trial with the Clinical Trials
Office, and other start-up information,
consult the
Office of Clinical Research's Clinical Trials Handbook. For a direct link to the
page with downloadable
AAA form, click here.
Our administrator can help (598-4701).
Please note: if you are requesting leukapheresis, you will need a AAA account. Please
review the leukapheresis policies and let us know
if you have any questions.
Provide final copies of the following documents to the administrator:
- Approved final revised GCRC SAC application (we will provide)
- Documentation of HSD approval including a copy of the current case report forms, current approved HSD application, consent form and correspondence related to the initial IRB approval
- Draft of study orders
- For industry studies, you must provide a finalized contract prior to seeing subjects in the GCRC
Once the above steps are completed, we can:
Schedule a Study/Protocol Implementation Meeting
Attendees at the meeting will include the PI and/or research coordinator and other study
staff, GCRC Nurse Manager and/or the GCRC nurse who will be designated as the primary
nurse for the study, and at least one additional GCRC nurse. A typical meeting lasts
between 60 and 90 minutes.
- Introduce the P.I.'s study staff to their primary GCRC nurse
- Overview of the study (presentation by the P.I. or designee)
- Review forms, e.g. CRFs, eligibility checklist, orders for the study
- Finalize study orders
- Review roles and responsibilities of each team member
- Walk through a typical visit
- Determine all emergency contacts
- Assess what, if any, new skills are needed by the GCRC nursing staff and whether training is completed
- Review procedures for obtaining and processing specimens
- Evaluate equipment and supplies necessary to perform the study
- Review scheduling process
- Review ongoing documentation requirements of the GCRC which include:
- A copy of the consent & HIPAA forms signed by the participant and PI (or designee) prior to seeing a patient for the initial visit
- A copy of the signed eligibility checklist
- Copies of the DSMB or safety monitor's report (if applicable) as soon as possible after receipt by the PI.
- Copies of all IRB approved documents as soon as possible after approval including:
- The original application and all correspondence related to the initial approval. To include the approved consent form(s).
- All subsequent modifications along with revised consent form(s) or protocol as appropriate.
- All subsequent renewals
- All Serious Adverse Event reports
- Review approved ancillaries
- Review any research billing
- Discuss any outstanding issues
|
A copy of the minutes from the implementation meeting will be provided to you for your
regulatory file.
If your study does not enroll a patient within 90 days of the Study Implementation Meeting, then
another SIM must be completed.
|