OCR Intake Form

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Please complete the survey below.

Contact the Office of Clinical Research at musc-ocr@musc.edu or 792-7900 with any questions.

Thank you!

OCR Intake Survey Guidelines

Please complete the OCR Intake Survey with the most accurate and up-to-date information possible. If anything changes following submission to the OCR, as is often the case in research, please contact the OCR Intake Coordinator at musc-ocr@musc.edu to notify the OCR of those changes as they may impact one or more OCR service providers.

Prospective Reimbursement Analysis (PRA) Notes:

The PRA Team's ability to perform the PRA, which may include, but is not limited to, building SPARC Calendars and completing the Coverage Analysis, depends upon the Study Team's timely and effective cooperation. The PRA Team may rely upon the accuracy and completeness of any data, documents, or other information provided by the Study Team via this Intake Survey and the request in SPARCRequest.

**Please contact the PRA Team immediately if there are any changes to the information provided in this form.**

Clinicaltrials.gov Requirements

When a PRA/PRA Exception Service Request is submitted via SPARC, the Clinicaltrials.gov Compliance team will assess if the study requires Clinicaltrials.gov registration by the MUSC study team. Once the review is complete, documentation will be uploaded in the SPARCDashboard and when applicable, the Clinicaltrials.gov Coordinator will contact the study team to assist with the registration process.

RMID Number

To look up your RMID, go to the RMID website.

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Name of Person Completing Intake Form

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Are there other members of the study team and/or service providers who should be included in OCR and/or PRA communication?

TIP: The "requester" or "primary contact" should download the pdf of the Intake Survey after completing this form to save to study records and share with the other study team members.

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Yes

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Please list the names and/or email addresses of other individuals to include in communications:

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Have you performed a feasibility assessment for this study?

Note: This may include completing a site selection form for a Sponsor or Lead Site.

Yes

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Please select all feasibility tools used:

Sponsor provided feasibility assessment

Internal feasibility assessment

Self-service patient count tools (e.g. Epic SlicerDicer, TiNetX, i2b2)

Other patient count tool tool to obtain recruitment estimates (e.g. Registry Data)

Please indicate which self-service patient count tools were utilized:

Epic SlicerDicer

TriNetX

i2b2

Please indicate which patient count tools were utilized:

The Office of Clinical Research Finance Team is offering services which includes budget development and sponsor negotiations. The cost for this service is a one-time fee of $2,750 to which the 30% corporate overhead rate will be applied.

Are you interested in this service?

Yes

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Additional OCR Finance Service Fees
An annual invoicing maintenance fee of $775 will apply for studies utilizing the OCR Sponsor Invoicing service.

A budget/invoicing amendment fee of $550 will apply to budget/CTA amendment facilitation and updating invoicing workflows during the sponsor invoicing phase, if applicable.

For very high volume invoicing studies, additional invoicing monthly maintenance fees may apply.

Will this study be prospectively recruiting participants?

TIP: If the study involves consenting participants OR if the study has a "waiver of consent", this question should be answered "yes."

NOTE: "PROSPECTIVE STUDIES - Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data." As defined by MUSC IRB Policy and Procedure 1.3, item 203.

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Yes

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Does this study involve ONLY survey(s) or data collection (from the medical record)?

Note: Data collection may include surveys/questionnaires, data collected prospectively from the medical record , etc.

**If the study involves any clinical procedures (i.e. blood draw, medication administration, vital signs, etc.) then it is NOT considered a survey or data collection only study. Please select "No."

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Yes

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Does this study involve cancer patients or cancer related aims?

TIP: Cancer related trials include cancer prevention, diagnostic; or other cancer-related epidemiological study that may enroll healthy patients without a cancer diagnosis.

Yes

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How many participants do you anticipate enrolling?

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Anticipated recruitment start date

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M-D-Y

Will you be compensating study participants?

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Yes

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Would you like to use a reloadable MasterCard (ClinCard) to compensate participants?

Note: Check "No" if the Sponsor is providing the ClinCard.

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Yes

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Does the study budget that is provided by the Sponsor or grant budget provide lump sum costs only?

Note: By "lump sum costs" we are referring to per visit fees or "total patient costs" rather than a matrix style budget or a budget that breaks down the costs of each visit by study procedure.

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Yes

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For studies with only a "lump sum" budget available, it will be necessary for the study team to provide a matrix style budget or a line-by-line budget that includes what each payment in the original budget is inclusive of. Please upload the requested documentation in SPARCDashboard. A template matrix style budget can be requested by emailing: ocrtraining@musc.edu.

In the event that the study team does not provide this payment breakdown, the PRA Team will generally assume the payment is inclusive of all related items in the protocol. Changing this approach after the Study Billing Plan has been completed will result in a PRA Amendment and associated fees.

Is this study being submitted to the IRB under an Exempt Review category?

Tip: Refer to this IRB policies and procedures document to review Exempt Categories.

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Yes

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Has this study been submitted to the IRB?

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Yes

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Target IRB Meeting Date

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M-D-Y

Please include any additional information regarding institutional approvals that has not already been identified.

i.e. Institutional Biosafety Committee review, Hollings Cancer Center PRC, etc.

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Please select all MUSC Health locations where study visits will occur:

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Charleston

Other MUSC Regional Health Network Site

Other MUSC Affiliate Site

Non-MUSC location

Specify the non-MUSC location(s):

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MUSC RHN sites and/or MUSC Affiliate sites were selected as locations for study visits. Please note another Intake Survey Form will be automatically generated for your completion. Please complete the additional form. If it does not appear, please reach out to the OCR for assistance at musc-ocr@musc.edu.

The following questions apply to study visits occurring at MUSC Charleston only.

MUSC CHARLESTON - Select all locations where study visits will be performed:

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SCTR Research Nexus, outpatient research clinic

On-campus outpatient clinic

Off-campus outpatient clinic

Inpatient floor

Emergency Room

Investigator Lab

Other Dedicated Research Space

Other

Specify the Other Space to be utilized:

Tip: Be as specific as possible.

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Please indicate which visits will take place or most likely take place as Nexus Visits:

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Please indicate which visits will take place or most likely take place as Inpatient Visits:

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Select all individuals that will be performing any study procedures or assessments:

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Study Staff (Coordinators, PI, etc.) or Nexus Research Coordination and Management

Clinical Staff (clinic/floor nurses, phlebotomists, radiology techs, etc.)

Nexus Clinic Staff (MUSC Health Charleston)

Other

Specify Other Staff:

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Please indicate which protocol visits (or procedures) will be performed by Research Nexus staff:

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Please indicate which protocol visits (or procedures) will be performed by MUSC Health clinical staff:

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Will this study involve any Remote Visits? These include visits conducted by video, phone, email, etc.

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Yes

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Will remote visits be scheduled and/or documented in Epic?

(This includes remote visits conducted via MyChart)

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Yes

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Who will be performing the remote visits?

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Licensed Clinical Staff (includes clinical members of the study team)

Unlicensed Research Staff

Other

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Specify Other Personnel performing Remote Visits:

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Please select ALL services that are included in the study protocol.

Note: This also includes any services that may be performed as "standard of care."

Example: The study requires a blood draw. The blood draw will be performed by the Nurse Coordinator, processed by the Research Nexus and analyzed by a central laboratory. Please select "yes" for "Lab Samples", select "Nexus Lab" for the lab location that will be preparing the samples for shipping, and select "Central Lab" for the lab where the tests will be analyzed/resulted.

Yes

Lab Samples (Includes all biological specimens: blood, urine, stool, tissue, spinal fluid, saliva, etc.)

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Electrocardiogram (ECG)

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Radiology/Imaging

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Investigational Drug Services

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Eye Exams

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Audiology Tests

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Select the lab(s) where the tests will be analyzed/resulted:

Please review the Nexus Lab services in SPARCRequest for details on labs performed by the Nexus Lab.

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Central Lab

MUHA Lab

Nexus Lab

Investigator Lab

Other

Select the lab location that will be preparing the samples for shipping:

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Nexus Lab

MUHA Lab (after hours processing only)

Investigator Lab (or processed by study team)

Other

Is there a chance that any of the central labs may be performed locally for any reason?

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Yes

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List the lab tests that may be performed locally:

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Specify Other Lab:

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Specify Other Lab:

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Select the ECG machine information that best applies:

Note: Please select all locations for all ECGs that may be performed, including "standard of care" ECGs.

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ECG machine provided by sponsor

ECG machine operated by the Study Team

ECG performed by Cardiology (in the hospital/clinic)

ECG machine in the Nexus

Other

Describe which ECG machine will be used and who will be operating the ECG machine:

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Select who will be reading (interpreting) the ECG report:

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Tracing will be sent to Central Lab

Tracing will be read by Study Team (Investigator)

Tracing will be read by Cardiology

Other

Describe who will be interpreting ECG printout:

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If the research ECG machine isn't working or a study investigator is unable to read the printout, will MUSC Health ECG resources be utilized for this study as a back-up or alternative?

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Yes

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Select the location where radiology/imaging will be performed:

Note: Please select all locations for all imaging that may be performed, including "standard of care" imaging.

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Hospital (ART, Rutledge Tower, etc.)

30 Bee St (Research space)

Off-campus

If the MRI at 30 Bee St is unavailable, inaccessible or inoperable, will MUSC Health MRI machines be used as a back-up or alternative for this study?

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Yes

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Per study Protocol and/or Imaging Manual, does this study require specific imaging parameters that would not be considered routine if the subject was not participating in this study?

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Yes

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Who will be performing the eye exam?

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Study Investigator

MUSC Health Staff (Ophthalmology Department)

Other

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Describe who will be performing the eye exam:

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What type of SmartSet (standing orders) will this study use?

Note: All studies with MUSC Health Services are required to have a minimum of a "Simple Order Set."

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Simple Order Set (free of charge) - A simple pick list of research orders to support the study team to choose the orders for each participant's study visit

Advanced Order Set (fee-for-service) - Orders broken out into visit specific sections allowing the study team to easily see which orders are required per visit.

Supportive Care Plan (fee-for-service)/ Beacon Treatment Plan (HCC Only) - Research orders, as well as study tasks or directions to be completed at specific time points or visits, built in a visit specific format

I do not think there are any orderables in my study -- I understand this will be reviewed by the PRA and Epic Research teams who will determine if an order set is required. In which case, a Simple Order Set will be provided.

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Please include any additional information regarding performance or location of study procedures that cannot be identified in the protocol or other study documents.

Examples: Participation in sub-study? Not participating in all parts/phases/cohorts? Etc.

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Provide any other information that is relevant to the start up of this study that has not been addressed above.

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Probable PRA Exception
If your study is not prospectively recruiting participants, or was submitted to the IRB under an Exempt review category, please submit a "Prospective Reimbursement Analysis Exception" in SPARCRequest , if you have not already done so.

If you have already submitted a PRA Request, the OCR Intake team will review this form and submitted documents and provide a PRA Exception letter if applicable.

Cancer Studies
As an NCI Designated Cancer Center, ALL cancer related trials are required to be reviewed by the Hollings Cancer Center Protocol Review Committee. Please go to the PRC website for more information about this process, or contact Kristin Britton, PRC Administrator at 843-792-9247.

Feasibility
If you have not completed a Feasibility Assessment for this study, it is recommended that you refer to the self-service feasibility tools or request a Feasibility Consult via SPARCRequest.

Self-Service Feasibility Tools or

Self Service Research Data & Feasibility Consultation via SPARCRequest

Budgeting and Invoicing
You indicated that you are interested in the OCR Budgeting and Invoicing service. The OCR Intake Team will submit a request in SPARCRequest for these services on behalf of the study team. A member of the OCR Finance Team will contact you regarding the request.

If you have any questions about the service, please contact the OCR Finance Team at ocrinvoicing@musc.edu

ClinCard
You indicated that you are interested in using ClinCard as participant remuneration for this study. The OCR will add a ClinCard service request in SPARCRequest for your study. A member of the ClinCard Team will contact you about the request.

Nexus Clinic and/or Lab Services
You indicated that services will either be performed in the Research Nexus Clinic or that Nexus Clinic Staff will be performing study procedures. The PRA Team will add the request for Nexus Clinic/Lab services on behalf of the study team. You will be contacted by the Research Nexus Navigator to coordinate the set up of your services.

Radiology Services
You indicated that this study requires radiology services. The PRA Team will submit the Radiology Intake Service in SPARCRequest on behalf of the study team. The Radiology Dept. will review the study documents to determine the level of Radiology Research Review required and to ensure the correct radiology services are identified for this study.

Note: If this study requires special imaging parameters in order to collect the study-required imaging, the Radiology Department will review these special requirements to determine if the required imaging is within MUSC Health current capabilities. You will be contacted by the Dept. of Radiology with any special instructions or limitations.

Please login to SPARCDashboard for this study to complete the Radiology Form as soon as you are notified of submission of the radiology services.

**Please submit all imaging documentation (manuals, etc.) in SPARCRequest as soon as possible in order to prevent delays to this review.**

Ophthalmology Services
You indicated that this study will required ophthalmology services from the Department of Ophthalmology. The PRA Team will add the Ophthalmology Protocol Review (Level 1) Service to SPARCRequest on behalf of the study team. However, the study team will be responsible for coordinating their service needs and ensuring proper set-up/workflow prior to study start.

Audiology Services
You indicated that this study will require audiology services from the Dept. of Audiology. The PRA Team will contact the Dept. of Audiology to notify them of a pending study requiring audiology services and to confirm CPT codes for the study calendar if necessary. However, the study team will be responsible for coordinating their service needs and ensuring proper set-up/workflow prior to study start.

Budgeting and Invoicing
Add OCR Corporate Budgeting and Invoicing service to SPARCRequest.

ClinCard
Add ClinCard New Study Set Up service to SPARCRequest.

Potential Lump Sum Budget
Check SPARCDashboard for a matrix style or line-by-line budget document to accompany the "lump sum budget" provided by the Sponsor and/or grant. If one is not available, remind the study team to submit one or notify them the assumption made by the PRA Team is that the payments are inclusive of all protocol required services.

Radiology Services
Add Radiology Intake Service to SPARCRequest.

Special Radiology Services
Add Radiology Feasibility Service to SPARCRequest.

Nexus Services
Add Nexus Intake Service to SPARCRequest.

IDS Services
Add IDS Moderate Category for Study Setup/Initiation service to SPARCRequest.

Ophthalmology Services
Add Ophthalmology Protocol Review (Level 1) Service to SPARCRequest.

Audiology Services
Contact the Dept. of Audiology to notify them of pending study requiring audiology services. Refer to contacts list for current contact information.

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