John Sealy Hospital, 5th floor, J5A Outpatient, J5B Inpatient,  J508 Administrative Offices, route 0264,

Voice: 409-772-1950, Fax: 409-772-8097

 

 

Type of Study

View/Read:

GCRC Application Instructions

DSMP

GCRC Notices

Download:

Protocol PHS 398 Template

Resource Request Form

Link to:

NIH Biosketch Form

IRB Human Subjects Training

IRB Forms

Other Useful Links

 Last Modified: 10/11/03

 

The extent to which the GCRC can fund the costs of research testing and hospitalization for a study depends upon a categorization of the study’s outpatient and scatter-bed activity. This patient categorization is made by the Program Director and GCRC Advisory Committee (GAC) in consultation with the principal investigator. The categories are as follows:

Questions concerning study categories should be addressed to the GCRC staff by calling x21950

 

“A” Study:

This category includes studies that are investigator-initiated where subjects are seen at the GCRC specifically for research. The GCRC pays for the inpatient days and outpatient visits and may agree to pay for ancillary costs that are described in the approved protocol. If costs exceed the ancillary budget of the GCRC, some are then paid by the investigator’s own grant. An investigator-initiated study may be sponsored by any source, including industry. Preference for use of GCRC resources is given to federally funded studies (especially NIH). Priority is also based on scientific merit.

"B" Study:

This refers to investigator-initiated studies where patients are seen at the GCRC as inpatients or outpatients for research, but also require standard clinical care at the same time. The costs related to research are paid by the GCRC, as for “A” studies, and costs related to standard of care are charged in the usual manner to the patient or health insurance.

"C" Usage:

This refers to use of the GCRC entirely for service rather than research. For example, GCRC facilities may be used when beds or clinic space is not available elsewhere, or when a patient requires service that is best provided at the GCRC. Costs are charged to the hospital, the patient or health insurance.

"D" Study:

 Studies in this category are industry-initiated. All costs to the GCRC related to the research are charged to a UTMB grant account funded by the pharmaceutical company. With special permission, “D” studies can include investigator-initiated “A” components that are paid by the GCRC.

 

The links provided below will help you in this process...

(Download this set of instructions)

BEFORE your Protocol can be Approved
AFTER your Protocol has been Approved

REQUIREMENTS FOR USING THE GCRC

INVESTIGATOR’S RESPONSIBILITIES

TYPE OF STUDY

STUDY INITIATION

GCRC APPLICATION PACKET & INSTRUCTIONS*

ACKNOWLEDGING THE GCRC

GCRC ADMINISTRATIVE STAFF

ANNUAL REPORTS & RENEWALS

GCRC APPLICATION REVIEW PROCESS

CLOSING A GCRC PROTOCOL

*download/save file to your computer