U of Iowa GCRC: Submitting a Protocol

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IowaGCRC

General Clinical Research Center

Submitting a Protocol

Obtain GCRC protocol application form here.
- Complete required information including gender and minority demographic data.
- Complete the required education on the Protection of Human Research Subjects. You cannot admit subjects to the GCRC unless you have completed this training.
- Complete a Research Safety Monitoring Plan, which is included in the protocol application.

Consult with the following as appropriate

Contact ...	For advice on ...	Phone
William Haynes, MD Program Director	approval process and protocol costs	384-8305
Leon Burmeister, PhD Biostatistician (required for all protocols)	sample size, statistics, and study design	384-8321
Mary McDermott Administrative Manager	budget and reimbursement	384-8319
Michael-Bosch, RN Nurse Manager	recruitment and patient care	353-6250
John Widness, MD Associate Program Director	scatter nurses	356-8102
Daryl J (DJ) Murry, PharmD Core Laboratory Director	analytical core and physiology core services	335-8752
Clark Stanford, DDS, PhD Associate Program Director	oral and craniofacial component	335-7381
Phyllis Stumbo, PhD, RD, LD Nutrition Manager	diet and anthropometry	384-9746
Chuck Dayton, RPh Associate Safety Monitor	data safety monitoring plans	356-4398

Email GCRC application to mary-mcdermott@uiowa.edu

Prepare a simultaneous application to the Institutional Review Board:

   Western Institutional Review Board (WIRB) for industry-sponsored AND
    industry-initiated studies. See the UI/WIRB webpage for more information.

    IRB-01 for all other protocols

    If applicable, submit applications to the Pharmacy and Therapeutics and
    Medical Radiation Protection Committees.

Your questions about protocol preparation or IRB requirements can be answered by the Nurse Manager (353-6250) or Program Director (356-2974).

Note: The protocol review process takes about four to six weeks. The protocol will be reviewed for scientific merit, safety and appropriate utilization of GCRC resources by a member of the GCRC Advisory Committee and two reviewers with expertise in the area of investigation.

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