Investigator Information

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

1. Pre-submissionIt 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 Nurse Manager, Cyndi Flanagan chf117@psu.edu  to set up a meeting or for additional information about applications or resources available.
2. 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).
3. CRC Advisory Committee review: The final step in the application process is approval by the Advisory Committee or by review by the CRC medical staff. 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. Each protocol is reviewed as follows:
   
   1. If resource request is for space, freezer accommodation, help with training staff in lab procedures, other non-human clinical procedures, or other requests reviewed by CRC physician and assigned low risk, the application may go through an expedited review process and not be assigned for peer research faculty nor statistical review. Science Review Committee will be informed of the expedited review at next meeting. If, in conduct of the protocol at the CRC or in approved PI lab, additional risks emerge or procedural activities warrant review, PI will be informed and full committee review may be warranted.
   2. If the protocol has undergone a scientific peer review and/or has internal or external funding (i.e. NIH) that includes a peer review, the application can go through an expedited review process.  The protocol will be reviewed by the nurse manager and if it is defined as only needing an expedited review, one of the CRC physicians will review the protocol and approve the protocol for CRC services.  The Science Review Committee will be informed of the expedited review at next meeting.
   3. If use of resources is for procedures involving human clinical activities in a study protocol and has not undergone scientific peer-review or external funding, it is assigned for review to member of the CRC Science Review Committee and representative from the CTSI BioStatistics Core (BERD). Reviews are submitted prior to the monthly committee meeting and discussed with committee members.  Committee members, after discussion, can vote to approve the use of the CRC resources requested, approve pending submission of requested information or ask for additional information/response/clarification prior to approval. PI will be notified of the committee or medical staff response.
4. 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 Nurse Manager, Cyndi Flanagan chf117@psu.edu.

Links to Forms

Click here to access the online CRC Application for Services.

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.

The CRC operates on a fee-for-service basis. If you are interested in a service not listed here, please contact the CRC Nurse Manager, Cyndi Flanagan, at chf117@psu.edu.

• Clinical Research Center Fees

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 nurse manager, Cyndi Flanagan chf117@psu.edu , for more information.

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.

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 [and the Penn State College of Health and Human Development]. 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, Shaweta Gupta Singla, sug450@psu.edu.