Investigators from across Penn State, without regard to college or campus, are welcome to use the CRC. Services are available to investigators on a reduced fee-for-service basis.
- Application Process
IRB and CRC applications can be submitted simultaneously, although any research involving human participants must have IRB approval before beginning work at the CRC.
Protocols submitted up to two weeks before the meeting date will be brought to the committee for that month. The committee tries to return reviews as quickly as possible, but investigators should allow 3 weeks for review before they plan to start their study. Sometimes, the reviewers identify procedures that need to be updated or changed through an IRB modification. Allow time for this.
2021-2022 CRC Science Review Committee Meeting Dates: generally the 3rd or 4th week of the month, Zoom format
- Pre-submission: It is highly recommended that you meet with the CRC staff before you finalize your CRC and IRB applications. This meeting can identify unique needs of each protocol. The CRC team can discuss feasibility of various procedures and make suggestions about how to handle planning and logistics. Contact CTSI Program Manager, Dee Bagshaw, email@example.com to set up a meeting or for additional information about applications or resources available.
- CRC application submission: The application for CRC services is now online (click here). Please note that you will need to upload either a graphic representation or an outline of the study steps/timeline. A representation of the visit sequence for multi-visit studies, and/or within-visit sequencing for complex visits, makes it much easier to understand what you are looking for from the CRC. In addition to the brief CRC application, we require all relevant IRB documentation (protocol, data and safety monitoring plan, and informed consent form).
- CRC Advisory Committee review: The final step in the application process is approval by the Advisory Committee, which meets on a monthly basis. The CRC review process has three goals: 1) to offer advice to enhance science, 2) to provide a second review of safety, and 3) to ensure that the CRC has the resources to meet your request. Protocols submitted up to two weeks before the meeting date will be brought to the committee for that month. The committee tries to return reviews as quickly as possible, but investigators should allow 3 weeks for review before they plan to start their study. Sometimes, the reviewers identify procedures that need to be updated or changed through an IRB modification. Allow time for this.
Modifications to CRC protocols: Any modification to an existing CRC protocol must be submitted to the CRC as well as the IRB. In order to simplify the process for investigators, a copy your correspondence to the IRB outlining the proposed changes should be sent to the CTSI Program Manager, Dee Bagshaw, (firstname.lastname@example.org).
Review Meeting: Materials Due:
April, 2021 April 15, 2021
May, 2021 May 15, 2021
June, 2021 June 15, 2021
July, 2021 July 15, 2021
August, 2021 Aug. 15, 2021
September, 2021 Sept. 15, 2021
October, 2021 Oct. 15, 2021
November, 2021 Nov. 15, 2021
December, 2021 Dec. 15, 2021
Links to Forms
It is possible to begin the form, save it (you’ll receive a personalized link for your form), and then return later to complete the application.
Standard nursing hours: 7 am – 4 pm, Monday-Friday
Standard nutrition service hours: 8 am – 5 pm, Monday-Friday
The CRC has some flexibility in service hours, including on the weekends, depending on the research study in question and staff availability. Contact the program manager, Dee Bagshaw, email@example.com, for more information.
- Biostatistics Support
Investigators are encouraged to consult with the CTSI’s Biostatistics, Epidemiology and Research Design (BERD) group at University Park during the early stages of study planning. BERD is a one-stop shop for researchers who need study design, biostatistical, and data management expertise. Initial consultations are provided free of charge. Read more information about BERD services.
- Citing the Grant
The Clinical Research Center is a unit within Penn State’s Clinical and Translational Science Institute (CTSI). The CTSI is funded by a grant from the National Center for Advancing Translational Sciences (NCATS).
For purposes of continued support of the CTSI and CRC, we request that you document the use of any CRC services in all publications using the following language:
The project described was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant 1UL1TR002014-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
All manuscripts should comply with NIH Open Access policy. Please also send copies of all published manuscripts, articles, or abstracts based on research performed with CRC services to the CTSI Program Manager, Dee Bagshaw, firstname.lastname@example.org.