|
Your First Application to the GCRC
|
|
Annual Reports
Every year, the GCRC is required to collect a brief progress report for each study that uses
GCRC resources. This information is submitted with other information about GCRC activities to
our funding agency, the National Center
for Research Resources, a division of the NIH. The NIH uses these reports to assess GCRC
progress over the past grant year and to present data to Congress in support of NIH funding.
We appreciate your timely and thorough response to the request you will receive each spring.
Publications List
The publications list is considered the single most important indicator of GCRC productivity.
- Please list any publications in peer-reviewed journals based on research supported by GCRC resources.
- We are required to report which studies supported each article. For each peer-reviewed journal article, please indicate the GCRC study # or title.
- Please include publications in print or "in press" and their acceptance dates for the period specified when we contact you.
- We need reprints too.
- Also include any now publications based on information from any past GCRC studies.
A few reminders:
- If you used the GCRC for part of a multi-center study, don't forget to let us know about those publications.
- If someone in your lab published on research supported by the GCRC, and the PI of the study was NOT listed as co-author, we need to know about those articles!
Published acknowledgements of GCRC support are used
to measure our productivity. It impacts our funding and thus our ability to support you. Please
remember to acknowledge your use of GCRC resources in all publications based on research we
have supported. Thank you for your cooperation!
Progress Report (maximum: 1 page)
NIH staff will use this information to evaluate the GCRC. Your progress report needs to
include the following information:
- Number of new subjects enrolled for the period specified when we contact you.
- Total number of subjects enrolled since study initiation.
- Any changes in recruitment plans that might be needed.
- Unexpected safety concerns and their resolution.
- Interim data and outcomes if appropriate.
- Proposed changes made or anticipated in the protocol.
Lay Abstract (maximum: 250 words)
The NIH requires a brief abstract written in lay terms for inclusion in the public CRISP
database. Please include background, rationale for the project, study question(s), design,
study population, and outcome measures. Since the abstract is intended for the general
public, you should not include any proprietary information.
If you submitted an abstract for the previous year's report, we will send you a separate
email enclosing that abstract for review.
Other Support
The NIH requires reporting on all research support being granted to GCRC PIs and co-PIs. All research
support (grants and contracts) information must be reported for the PI and each of the co-PIs on the
study that is related and unrelated to the study.
- Please indicate if the grant is NIH funded, the agency or the grant source, grant number (if applicable), start date, end date, and total grant amount.
- Please highlight the grant(s) that directly support your GCRC study.
- The funding amount is required by NIH; if there is no amount listed the grant cannot be reported.
- Please add direct and indirect cost together for the total grant amount.
- If a grant is awarded per patient please provide an estimated amount.
NIH Vocabulary
- Census – If any subject for any reason (screening, follow-up, etc.) has visited the GCRC for your study during the reporting period, then your study has acquired census.
- Cores – The cores include Biostatistics, Bionutrition/Body Composition, Informatics, and the Gene and Cell Therapy Core Lab.
- Enrollment – Participants who meet all eligibility requirements and are randomized to treatment.
- SPID – (Study Protocol ID number) The number given to a study by the SAC (Scientific Advisory Committee) when it is first approved on the GCRC.
Thank you very much for your cooperation! Please call
Kathy Long at
(206) 598-4700 if you have any questions.
|