GCRC Application and
Submission Process
| |
REQUIRED ELECTRONIC
SUBMISSON
|
REQUIRED HARDCOPY
SUBMISSION |
DOWNLOAD FORM
|
| GCRC Application is comprised of the complete GCRC
Application and the Data and Safety Monitoring Checklist. |
X |
|
Link to
Online Application |
GCRC Submission Checklist: The new application
is required for ALL protocols submitted after the March 7th, 2005 submission
deadline.
Please submit your printed version of the application checklist along with the
rest of the required hardcopy documents to the GCRC Administration office.
|
|
X |
Download
Submission Checklist |
| Protocol Format Requirements: The protocol is
required in GCRC format* NIH protocol format (this format required by the GCRC
can be utilized when submitting this protocol the HSC). Please see the REQUIRED
format requirements |
|
|
Download
Format Requirements |
Protocol: The protocol must be submitted in GCRC
required format* NIH protocol format (this format required by the GCRC can be
utilized when submitting this protocol the HSC). Please see the downloadable
protocol template to the right or see website
http://grants1.nih.gov/grants/forms.htm downloadable instructions and
form files.
The GCRC protocol MUST include a
Data Safety and Monitoring Section.
The GCRC protocol MUST include
GCRC Needs and Requirements Section
|
X |
|
|
Informed Consent:
Approved/Stamped Consent (if available: If the approved/stamped consent is
unavailable, please include copy of what was submitted to HSC)
|
X
(Optional) |
X |
|
| Applicable Budget Information:
|
|
X |
|
| Investigator’s Brochure: One copy for any clinical
trial conducted under an IND/IDE. |
|
X |
|
| Biographical Sketch: Use NIH form 398 and format
for each investigator listed on
the project. |
|
X |
Download
Biosketch Template |
Note: After final approval by the
GCRC Advisory Committee and HSC, the investigator will also need to provide for
the duration of the study:
| |
REQUIRED ELECTRONIC
SUBMISSON
|
REQUIRED HARDCOPY
SUBMISSION |
DOWNLOAD FORM
|
| HSC Approval Letter: Along with copy of all
correspondence from the HSC |
|
X |
|
| Revised or Annual Recertification Approved Consent Form:
|
|
X |
|
Additional Requirements for Industry
–supported or Designed Research:
| |
REQUIRED ELECTRONIC
SUBMISSON
|
REQUIRED HARDCOPY
SUBMISSION |
DOWNLOAD FORM
|
| In the body of the protocol or by cover letter, indicate whether the research
is industry-initiated or investigator-initiated or designed. The latter will be
given much greater preference with respect to GCRC usage. |
|
|
|
| Is the study unique (in what way?) to the institution or is it multi-centered?
If multi-centered, will data be shared? Unique studies in which work done at
this institution can be published separately will be given higher priority. |
|
|
|
| Are there any limitations to publication? If so, it is less likely that the
study will be approved for GCRC use. |
|
|
|
| For both forms of industry related research, the GCRC Advisory Committee will
be responsible for allocating the extent to which the industry will be
obligated for the support of research conducted at the GCRC. |
|
|
|
| Industry Itemized Budget: 1 Copy is requested. |
|
X |
|
| Industry Protocol or the Protocol as approved by Industry:
1 Copy IN ADDITION TO the GCRC required format. |
X |
X |
|
| Industry Contract: 1 Copy is requested. |
|
X |
|
| Other Information: |
|
|
|
| Review Process: |
|
|
Link to
Review Process Flow Sheet |
| Policy for GCRC Outpatient Unit: |
|
|
Link
to Policy |
| Study Subject Categories: |
|
|
Download
Subject Category Information |