Navigating the Clinical Protocol Activation Process for Industry-Written and Sponsored Clinical Trials

The flowchart and steps below outlines the best practice for processing industry-written and sponsored clinical trials at UAB. There are many small steps in each of the larger defined steps (see flow diagram). Each step is very important and establishes a good foundation for the next. Note that as you navigate the process, while some steps are serial, most are parallel and there is a true flow to the process to get the desired outcome, which is to have all tracks of the process completed simultaneously.

This document is a living document and the flow is subject to change as some systems change or processes are streamlined. Please don’t hesitate to submit any questions, suggestions, or comments you may have to the Clinical Trials Administrative Office at This email address is being protected from spambots. You need JavaScript enabled to view it. and we will respond promptly.

 

GLOSSARY TERMS

  • CBR – Clinical Billing Review
  • CDA – Confidentiality Disclosure Agreement
  • CIRB – Conflict of Interest Review Board
  • CMS – Centers for Medicare & Medicaid Services
  • FDA – Food & Drug Administration
  • GCA – Grants & Contracts Accounting
  • HSP – Human Subjects Protocol
  • IRB – Institutional Review Board
  • NDA – Non-Disclosure Agreement
  • OCCC – O’Neal Comprehensive Cancer Center
  • OSP – Office of Sponsored Programs

 

FLOWCHART

Clinical Protocol Activation Process Flowchart Submit to Greenphire via FA-grantsaccting@ mail.ad.uab.edu Register for ‘Single Identifier’ PowerPlan Released OnCore Calendar Released Submit Final Budget to OSP Contract Executed If needed, PowerPlan built, tested, and validated OnCore Calendar Created, Validated, & Completed IRB Approval Received Negotiate Final Budget CBR Approval Received Apply appropriate expenditures including Effort Receive Pending Account from GCA Submit to CBR via FAP@uab.edu Send Study Summary to PowerTrials@ uabmc.edu Submit to OSP via OSP@uab.edu Submit to IRB via IRAP Complete OnCore Submission in REDCap Submit for Special Reviews as needed including: CIRB,... Create Research Study Summary for PowerTrials Develop Preliminary Budget & Create CBR Submission Create Extramural Checklist for OSP Draft Consent Form & Prepare IRB Submission Assess Protocol Site Initiation Determine  Interest

 

STEPS

 DETERMINE INTEREST

Initial Contact by Sponsor
  • CDA or NDA required?
    • Information about CDAs and the corresponding submission documents/process are available on OSP’s website.

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 ASSESS PROTOCOL

Assess Protocol to determine interest, opportunity, resources, and determine if planning to proceed. If yes –
  • Determine activities and related locations
    • Identify all potential study personnel
    • Budget considerations, will the protocol utilize any of the following:
      • Center for Clinical and Translational Science (CCTS) services
      • Category A or B Devices
      • Clinical billable services (services provided and/or billed by any UAB Health System location)
      • Other service providers (Dermatology Research, Ophthalmology, Radiology Research, etc.)
      • Any other departmental costs (personnel, file storage, additional review or start-up fees for other service providers (BMT/Apheresis or Pharmacy)
    • Special reviews/approvals required for the protocol:
      • Special reviews/approvals - potentially hazardous agents:
        RadioisotopesMicrobial agentsRecombinant DNA/RNA molecules
        Toxic chemicalsGene TherapyToxins
        NanoparticlesExperimental DrugsVaccines
        CarcinogensMutagensTeratogenics
    • Obtaining anatomic pathologic materials cells, tissue or organs (from any site) or clinical pathologic materials (serum, plasma, cerebrospinal fluid or non-tissue-based microbiologic specimens)?
    • UAB cancer patients involved?
      • Study conducted at any of the following locations/sites? (UAB Hospital, Highlands, Kirklin Clinic, Children’s Hospital, Eye Foundation, Jefferson County Department of Health)
      • Participants involved with contagious infections at UAB or Children’s Hospital?
      • Dispensing of drugs to participants at UAB or Children’s Hospital involved?

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 REGISTER FOR ‘SINGLE IDENTIFIER’

Process currently being implemented across campus. More information coming soon.

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 SUBMIT FOR SPECIAL REVIEWS (as applicable)

Conflict of Interest
  • Disclosures must be submitted to the Conflict of Interest Review Board (CIRB) by the Principal Investigator and any other person who is responsible for the design, conduct or reporting of the research including anyone who is involved in the informed consent process for human studies. Note: Conflict of interest disclosures must be submitted to IRB and will be forwarded to WIRB. For questions, call CIRB at 975-9691 or forward to This email address is being protected from spambots. You need JavaScript enabled to view it..
Scientific Merit
  • Department specific review, submit Protocol Oversight Review Form (FOR205) using departmental letterhead
  • OCCC Clinical Trials Review Committee (CTRC) – protocols that involve cancer patients at UAB must be submitted to the CTRC for review and approval (contact Aparna Tamhane 975-9877 or This email address is being protected from spambots. You need JavaScript enabled to view it. for information and submission forms)
Safety Project Review Panels (all information available in UAB IRB website and guidebook) Protocol Oversight Review Form (for HIV Clinical Vaccine Trials, including Exemption for the NIH Guidelines) Infection Control
  • UAB Hospital at 934-5324
  • Children’s Hospital at 939-9265
Pharmacy
  • UAB Hospital
    • Complete the Release of Drugs for Human Research Use-UAB Pharmacy (FOR217)
    • Send this form along with a copy of the Study Protocol, Investigator’s Brochure (if available), and Pharmacy Manual (if available) to This email address is being protected from spambots. You need JavaScript enabled to view it.
    • NOTE: allow 7-10 days for review
  • Children's Hospital
    • Submit a copy of the study protocol to: TCHA Pharmacy Department Attn: Adrienne Travis, 1604 6th Ave South, Dock A, Birmingham, AL 35233
    • TCHA pharmacy completes the TCHA Pharmacy Release Form (FOR218) and forwards to the Pharmacy director for signature.
    • TCHA notifies the coordinator when forms (3 copies) are ready for pick-up.
    • Principal Investigator signs all copies and returns 2 copies to TCHA pharmacy
Pathology (anatomic or clinical)
  • Complete and sign the Anatomic Pathology Release Form (FOR215) and submit along with a hard copy of the study protocol to the Office of the Director for Anatomic Pathology, Kracke Building, Room 506.
  • Complete and sign the Clinical Pathology Release Form (FOR216) and submit along with a hard copy of the study protocol to the Office of the Director for Clinical Pathology, West Pavilion, Room P230.
  • The Principal Investigator is contacted by phone once the form is ready for pickup.

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 CREATE EXTRAMURAL CHECKLIST FOR OSP

Submit all required documents, Checklist must be submitted with signatures, other documents must be submitted electronically to This email address is being protected from spambots. You need JavaScript enabled to view it.. For any other forms, please see the OSP forms webpage. If you have questions regarding required documents for submission to OSP, please contact your OSP Officer or email This email address is being protected from spambots. You need JavaScript enabled to view it..

NOTE: Negotiation of contract terms occurs in parallel with department budget negotiations; however, an executed contract is contingent on having a finalized budget, CIRB release and IRB approval.

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 DRAFT CONSENT FORM AND PREPARE IRB SUBMISSION

Draft IRB submission and Consent Form for applicable review board Note: Projects to be reviewed by WIRB are NOT forwarded until CIRB release is issued.

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 DEVELOP PRELIMINARY BUDGET AND CREATE CBR SUBMISSION

If using -
  • CCTS clinical services, (CRU) (NOTE: keep in mind to notify OSP of this decision as negotiations with Sponsors requires special contract language)
    • Complete CCTS Registration Form and include the following in the submission:
      • Schedule of Events (highlighting all services you wish CCTS to provide)
      • Consent Form(s)
      • Protocol (Grant application, sponsor protocol, study group protocol)
    • The Clinical Services registration form and accompanying documentation should be sent to: This email address is being protected from spambots. You need JavaScript enabled to view it.
  • Category A or B devices?
    • Complete a Clinical Billing Review (CBR) Submission Form, include required documents, and submit to This email address is being protected from spambots. You need JavaScript enabled to view it..
  • Other service providers?
    • Submit to applicable service providers (protocol, study manuals and department request form)
      • Boshell Diabetes CV MRI – Trina Corbitt at This email address is being protected from spambots. You need JavaScript enabled to view it.
      • Civitan Functional Neuroimaging Lab – Dr. This email address is being protected from spambots. You need JavaScript enabled to view it., cc: Autumn Alexander, This email address is being protected from spambots. You need JavaScript enabled to view it.
      • Dermatology Research – This email address is being protected from spambots. You need JavaScript enabled to view it.
      • UAB Hospital Research Pharmacy – Chris Chapleau This email address is being protected from spambots. You need JavaScript enabled to view it. and complete the UAB Pharmacy Release Form (FOR217)
      • Ophthalmology Research, Contact Karen Searcey at This email address is being protected from spambots. You need JavaScript enabled to view it. and complete the Ophthalmology New Account for Ophthalmology Research Exams (price request form)
      • Radiology Research (contact: This email address is being protected from spambots. You need JavaScript enabled to view it.) Include the appropriate Radiology forms, study protocol, and if applicable, study-related radiology manuals.
      • Tissue Procurement – Kathy Sexton, This email address is being protected from spambots. You need JavaScript enabled to view it.
      • Bone Marrow Transplant (BMT)/Apheresis – This email address is being protected from spambots. You need JavaScript enabled to view it.

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 CBR SUBMISSION

Does the trial include Clinical Billable Services? If so, please submit through CBR.

There are four submission types: Full, Device, Amendment, and Feasibility. Complete the CBR Submission Workbook and the relevant forms included (as listed below). After completion, submit to This email address is being protected from spambots. You need JavaScript enabled to view it..
  • Checklists for each Submission Type
  • CBR Submission Form
  • Laboratory Form (if applicable)
  • Flow Cytometry Form (if applicable)
  • Device Form (if applicable)
  • Complete Attachments (as applicable)
    • Billing Plan (for Full, Device, Amendment)
    • CTAW (for Feasibility Requests only)
  • Upload the following (or attach to submission email)
    • Final Protocol (or HSP)
    • Draft Consent
    • Completed Billing Plan
    • Draft Sponsor Budget (if applicable)
    • Lab Manual (if available)
    • If Device Trial, include
      • Draft Clinical Trial Agreement
      • CMS Approval Letter
      • FDA Letter with CMS Category

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 SUBMIT FOR CMS REVIEW (if applicable)

Category A or B devices that are investigator-initiated or with an FDA letter date prior to 01/01/2015?
  • Submit protocol, IRB approval letter, approved consent and FDA letter to the Office of Clinical Billing Review at This email address is being protected from spambots. You need JavaScript enabled to view it..
  • Upon receipt of CMS approval letter, the Office of Clinical Billing Review will forward a copy to the PI/Research Coordinator.
Using Category A or B devices with an FDA letter date after 01/01/2015?
  • Submit a copy of the CMS approval letter with your submission to the Office of Clinical Billing Review at This email address is being protected from spambots. You need JavaScript enabled to view it..

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 COMPLETE ONCORE SUBMISSION IN REDCAP

For trials that include clinical billable services through the UAB Health System, an OnCore calendar must be requested here.

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 CREATE RESEARCH STUDY SUMMARY FOR POWERTRIALS

All trials being conducted through the Clinical Trial Management System (OnCore) must have a Research Study Summary generated and submitted as a PDF to This email address is being protected from spambots. You need JavaScript enabled to view it. for posting within the Cerner EHR for patient-safety purposes at the point of care.

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 SUBMIT TO GREENPHIRE

Unless utilizing University checks for the payment of participants (or an exception is secured), a request should be submitted to Financial Affairs via This email address is being protected from spambots. You need JavaScript enabled to view it. to set-up a trial in Greenphire, the University’s participant payment system. You may find additional information on Greenphire at the CTAO site.

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 RECEIVE PENDING ACCOUNT FROM GCA

Grants & Contracts Accounting will automatically send a Pending Account to the designated Award Manager on the OSP Extramural Checklist so that the Department may begin allocating expenditures (including faculty and staff effort) to the trial’s appropriate account. These expenditures must be applied in a reasonable timeframe to avoid delays in the execution of the contract.

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 NEGOTIATE FINAL BUDGET (Department Administrator)

Department will negotiate final budget with the industry sponsor.

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 RECEIPT OF IRB, CIRB APPROVALS

Note: If the commercial sponsor requires compliance with ICH-GCP, UAB’s WIRB liaison will not release the WIRB approval required under IRB POL005 without confirming that the UAB key personnel listed on the WIRB Initial Review Submission Form have completed the appropriate training and the training is documented in the Blazer ID Enabled Dissemination/Recognition of Official Content (BEDROC).

UAB’s Conflict of Interest Review Board (CIRB) will notify OSP when the project has been reviewed against UAB’s Conflict of Interest Policy and will provide OSP notification that “it is OK to release funds upon award” as approval.

Note: In the vast majority of industry sponsored clinical trials at UAB the central IRB for your project will be WIRB. There is a requirement for CIRB review and release prior to the WIRB application being forwarded by the UAB WIRB liaison to WIRB for review and approval. The UAB WIRB liaison must receive and will review the statement of conflict or no conflict from CIRB ensuring that it matches the investigator WIRB Initial Review Submission Form. If your industry sponsored clinical trial meet(s) the criteria for review by UAB IRB, CIRB release is not a requirement for review and approval, but it is a requirement for OSP to issue your award.

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 SUBMIT FINAL BUDGET TO OSP

Once budget negotiations are concluded the department will notify OSP that the budget is final, providing OSP with the agreed upon budget in the sponsor’s per patient/per visit format. The internal budget should be forwarded to OSP at this time.

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 OSP CONTRACT EXECUTED

Once OSP has negotiated the terms and conditions of the contract, receives approval from the UAB IRB, receives communication from CIRB that the project is “OK to award”, and is informed by the department that the budget is final, receives the Hospital Letter of Agreement (HLOA), if applicable, and receives the final agreement from the company, the contract will be presented for institutional signature.

Note: In many instances the sponsor requires UAB to sign the contract first. As a result, the UAB executed documents must be returned to the sponsor for counter signature prior to the award being distributed.

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 OSP RELEASES FINAL AWARD TO GCA, PI, AWARD MGR, AND CONTACT PERSON

OSP will issue the final award and the PI, contact person, award manager and Grants and Contracts Accounting (GCA) will receive a notification email. The award will consist of the contract (terms and conditions of the project), the internal budget, and any third party documents, e.g. Letter of Indemnification (LOI), required to ensure that UAB is indemnified in accordance with its policy (LOI required when indemnification is not included in the contract).

Note: Due to administrative process it may take GCA up to an additional 5 days to process this award into an active account. If you have additional questions about the status, please contact Tina Ealy in the Grants and Contracts Accounting Department at 934-9388 or This email address is being protected from spambots. You need JavaScript enabled to view it..

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 SCHEDULE SITE INITIATION VISIT

Work with study sponsor to schedule initial site visit.

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