National Institutes of Health, Department of Defense, and Industry - Post Award - Clinical Research Roadmaps - Miami CTSI – Clinical and Translational Science Institute

National Institutes of Health, Department of Defense, and Industry - Post Award

Gather
Requirements

Obtain Contracts/ Awards
Training
IRB Submission & COI Clearance

Preparation

Confirm Study Readiness
Create Documentation
Financial Preparation

Conduct the Study

Study Begins
Screening Potential Study Participants
Schedule & Conduct Study Visits

Data Entry &
Study Management

Study Close Out
Study Management
Data Entry

Obtain Contracts/Awards

Obtain Notice of Award, fully executed inbound subcontract, or fully executed contract.
Office of Research Administration (ORA) provides copy of award letter or fully executed contract to Principal Investigator (PI) and Department highlighting key terms and conditions.
For NIH awards, the PI can check eRA Commons directly.
NOTE: Department of Defense (DoD) requires the completion of the post submission activity (required award information and documents) in eBRAP System before receiving the contract.

PI/delegated study staff review award terms and conditions and protocol to ensure appropriate management and oversight. PI/appropriate departmental support must communicate with the Office of Research Administration (ORA) Post Award to ensure compliance with terms and conditions. Confirm who, what, when, and how (including recruitment strategies), and discuss discrepancies between protocol text and schedule of events.

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Training

PI and study personnel complete all applicable required training (i.e., Collaborative Institutional Training Initiative (CITI), Conflict Of Interest (COI)*, Velos, HIPAA training, New PI training**, UChart training***, Cerner training**** (Jackson electronic medical records), etc.)

PI and study staff complete required interest disclosure process in the Disclosure Profile System (DPS)

Become familiar with all Human Subjects – related policies and Standard Operating Procedures at the University.

Research Policies at UM
Public Access Policy
Office of Research Administration Policies
Clinical Research Policies
Regulatory Compliance and Quality Assurance (RCQA) specific policies

*For questions about COI and the DPS, contact the Office of Disclosures & COI Management (DCM).
**For new PI training, contact Clinical Research Operations and Regulatory Support (CRORS).
***For Web-Based Training, contact MiracleTraining@JHSMiami.org; for JHS Cerner credentials/JHS Security Request form, contact CSC@JHSMiami.org.
****For UChart training, click here.

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IRB Submission & COI Clearance

4.	Submit protocol to Institutional Review Board (IRB), if not previously submitted. NOTE: Additional requirements for DoD: refer to HRP-318 in IRB library within eProst/IRB7, and appendix A-4 within the HSRO Investigator Manual. NOTE: If study includes pre-screening, submit HIPAA waiver (Health Insurance Portability and Accountability Act).
5.	Submit protocol modifications to IRB, if protocol or staff have been changed since being awarded.
6.	Ensure that the Disclosure Profile System (DPS) is completed for all study personnel, and Financial Conflict of Interest (COI) clearance obtained from the Office of Disclosure and COI Management (DCM). NOTE: To check project compliance for all personnel, log into the Research Reporting System (RRS) → go to “Project/Disclosure” tab → select “Project Compliance” →sort by InfoEd number.

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Financial Preparation

7.	Once conflict of interest (COI) clears, a new/existing account number is issued/extended. ORA notifies PI and Department of sponsored account number/receipt of award/contract. NOTE: If your project anticipates subcontracting to external entities, the subcontracting process should begin immediately. Outbound Subcontract Process Flow can be found here, under “Flowchart”.
8.	Once account number is established/extended, a petty cash account can be initiated (e.g., for participant payments). To order study supplies and petty cash, a UMeNet account must be established in the UMeNet/ARIBA system. PI or delegated Study staff/appropriate departmental support completes “UMeNet add account” form, and submits to purchasing.

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Create Documentation

9.	Create Regulatory Binder/Site Master File (may be provided by sponsor). For information on required study documentation, Standard Operating Procedures (SOPs), master file, etc. contact the Clinical Research Operations and Regulatory Support (CRORS), and visit International Conference on Harmonisation. Note: Study correspondence may be stored in the regulatory binder or in a separate binder
10.	Create Case Report Forms (CRF), data collection forms (if not provided by sponsor), and database. Research Electronic Data Capture (REDCap) is an application that allows users to build and manage CRFs and databases quickly and securely. The BioStatistics Collaboration and Consulting Core (BCCC) can assist in the development of study databases. NOTE: Investigator-sponsored Investigational New Drug (IND) or Investigational Device Exemption (IDE) must use Velos (Part 11 compliant) for all data management. For any other data management system, contact IT Strategic Operations for an FDA Part 11 validation review.
11.	Create Study Participants binders.
12.	Create training binder to store all training documentation (e.g., certificates of completion, etc.) Note: study-specific training will be stored in regulatory binder
13.	Create tracking system (paper, electronic) for each required study visit/assessment.

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Confirm Study Readiness

14.	Engage all third party facilities (e.g., clinical research units, comprehensive treatment unit, pharmacy, radiology, hospital wards, etc.).
15.	Engage Clinical Research Operations and Regulatory Support (CRORS) for monitoring or regulatory support, as applicable.
16.	Confirm that all study supplies are available, and in sufficient quantities. Note expiration dates.
17.	Confirm that laboratory facilities and arrangements for dispatching samples to lab(s) are organized, and that any special equipment that may be required will be available throughout the period of the study (e.g., centrifuge, freezer, etc.) Ensure chain of custody documents are created for investigational products and samples. Note: Confirm that all study lab facilities maintain and document temperature monitoring and maintenance/service reports.
18.	Conduct and document the Site Initiation Visit or protocol in-service (whether federally or industry-funded). The PI, Study Staff, research pharmacist, all personnel who will be a part of the clinical research study will attend. NOTE: Your study may also require study–specific training for clinical departments where study procedures will take place (e.g., echo lab, cath lab, radiology, etc.).
19.	Ensure all Institutional Review Board (IRB) and institutional specific approvals have been obtained (e.g., Jackson Health System, Veterans Affairs, University of Miami Hospital, etc.). NOTE: Additional requirements for DoD: Submit Human Research Protocol Submission Form to DoD Human Research Protection Office (HRPO) after UM IRB approval. Confirm approval (~3 months). NEVER START STUDY ACTIVITIES WITHOUT IRB APPROVAL AND EXECUTED CONTRACT/AWARDED GRANT.

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Study Registration

20.	Create a Protocol Registration and Results System (PRS) account to register study with ClinicalTrials.gov. For clinical trial disclosure information, contact Research Compliance & Quality Assurance (RCQA) office.
21.	Confirm the study has been registered in Velos by the PI or delegated study staff upon IRB submission/approval.
22.	Enter NCT Number (ClinicalTrials.gov Identifier) in Velos.
23.	If using Velos, enter the information required for listing your study in the Clinical Trial Search Tool (CTST) (e.g., keywords, therapeutic areas, and NCT #, etc.).

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Study Begins

24.	THE STUDY MAY BEGIN ONLY AFTER ALL THE STEPS ABOVE ARE COMPLETED.

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Screening Potential Study Participants

25.	Perform pre-screening, if applicable. Pre-screening requires Institutional Review Board (IRB) – approved HIPAA waiver (Health Insurance Portability and Accountability Act).
26.	Conduct Informed Consent Process and HIPAA Authorization.
27.	Provide a copy of the signed and dated Informed Consent Form (ICF) and a copy of the signed and dated HIPAA authorization to the participant.
28.	Document the Research Enrollment/Research Encounter: Enter participants into Velos within 48 hours of enrollment. Submit Jackson Health System (JHS) Research Encounter Form to JHS Office of Research within 24 hours. Complete Miami Veteran Affairs Healthcare System enrollment form (Contact: 305-575-7241). Refer to UM Clinical Research Participants Enrollment and Tracking Policy, available at Research Policies at UM.
29.	Send signed copies of HIPAA Authorization to Office of HIPAA Privacy & Security. Include Attachment 45 (accounting for disclosures) when applicable.
30.	Perform screening visit(s) as per protocol, and assign study participant ID.
31.	Send signed and dated copies of ICF to the following offices/sites, as applicable. Copies of Informed Consent Forms must be added to UM and/or JHS Medical Records if the subject is also a patient at UM and/or JHS, and if the study is conducted at UM and/or JHS facilities. For UMH in-patients, place a copy of the signed ICF in the hospital chart. For JHS in-patients, place a copy in the hospital chart. Upon discharge, the chart is sent to JHS medical records for scanning, and the ICF will be scanned into Cerner. For JHS out-patients/clinic, send to clinic chart/medical records. JHS Office of Research (within 24 hours of signing the ICF). Miami Veteran Affairs Healthcare System IRB Office. Miami Veteran Affairs Healthcare System medical records. Third party UM facilities, as required (e.g., Clinical Research Translational Site, Comprehensive Treatment Unit, Pharmacy, Radiology, etc.). *NOTE: The original signed ICF MUST remain as source document in the research study files.

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Schedule and Conduct Study Visits

32.	Schedule study visits. Use applicable system to schedule research appointments: UChart, third party facilities (e.g., Clinical Translational Research Site, Comprehensive Treatment Unit, Pharmacy, Radiology, hospital wards, etc.). For UM Clinics & Hospitals (UMHC), Jackson Health System (JHS), and UM Hospital (UMH), email researchapprequest@med.miami.edu, or call 305-243-0210. For Radiology Research Imaging, call 305-243-5512.
33.	Submit required study procedures forms to third parties facilities as applicable (e.g., physician treatment orders, lab requisition form, etc.).
34.	Perform study visit AS PER PROTOCOL.
35.	Complete Case Report Form/data collection form, and/or obtain documentation associated with study visits.

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Data Entry

36.

Enter Collected Data.
For Investigator-initiated Investigational New Drug (IND) or Investigational Device Exemption (IDE) studies: Plan to use Velos for all data management. For any other data management system, contact IT Strategic Operations for a FDA Part 11 validation review.
(e.g., Velos, RedCap, Excel, Access, SASS, SPSS, Web-based database).

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Study Management (Ongoing)

37.	Submit modifications (amendments), reportable new information (RNI), continuing reports, unanticipated problems (UPs), etc. to Institutional Review Board (IRB) as applicable. NOTE: If the modifications affect the study budget, contact the appropriate department support. PI/delegated study staff notifies Office of Administration (ORA) – PreAward of any modification. PI/appropriate departmental support initiates Proposal/Contract Routing Form-L (PCRF-L), or Proposal/Contract Routing Form-S (PCRF-S) based upon Decision Matrix, and submits to Office of Research Administration (ORA) via mra@med.miami.edu. All forms are available here.
38.	Verify and update ClinicalTrials.gov records every 6 months during the actively recruiting stage (if applicable).
39.	Report deviations and adverse events to IRB, and sponsor, as per IRB policies and procedures and sponsor protocol, as per applicable regulations. Issue participant’s payments/reimbursements on an ongoing basis and ensure that a W9 Form has been completed for all payments.
40.	When the study participants have completed their involvement in the study, dis-enroll them in Velos within 48 hours of completing participation, by changing the participant status to “Off-Study”. This ensures that patients are no longer flagged in UChart as research participants.
41.	Monitor the study (Quality Control). Studies may be monitored by external or internal monitors (Office of Clinical Research Operations and Regulatory Support – CRORS).
42.	Report all external audit requests/notifications: For audits related to Human Subjects (e.g., FDA, NIH, DoD, EMA and any other federal agency), contact Research Compliance & Quality Assurance (RCQA): (305) 243-4215. For all other audits, site visits, or desk reviews, contact the Office of Research Adminstration (ORA) at (305)284-3871.
43.	The Department of Defense (DoD) requires quarterly and annual technical progress reports. NIH requires annual technical progress reports. Financial reports will be concurrently submitted by ORA.

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Study Close Out

44.	Ensure that all study visits are completed.
45.	Ensure that all regulatory documentation is current, complete and filed correctly in the site master file/regulatory binder.
46.	Ensure that all subject files are complete (data collection forms, labs, notes to file, etc.).
47.	Ensure that all data queries have been resolved, and copies filed in the research binders.
48.	Ensure that a plan is in place to appropriately follow-up on ongoing adverse events, as per protocol requirement.
49.	Notify engaged ancillary departments involved in the conduct of the study (e.g., Clinical Research Translational Site, Comprehensive Treatment Unit, Pharmacy, Radiology, etc.) of study closure.
50.	Confirm that all Investigational Product (IP) has been returned or destroyed at the site, as specified in the study protocol, and that records of the return or the destruction are filed in the regulatory binder. File copies of study packing slips, shipment receipts, and study participants in the regulatory binder.
51.	Ensure that all other study-related materials (e.g., unused study kits, data collection forms, etc.) are returned or destroyed, as specified in the study protocol/operations manual/sponsor instructions.
52.	Ensure that any equipment on loan is returned.
53.	Ensure that final participant’s payments have been submitted and/or distributed (if applicable), and that W9 Form has been completed.
54.	Verify that all study participants have been dis-enrolled in Velos, to ensure they are no longer flagged in UChart as research study participants.
55.	Ensure that Purchase Orders (PO) are closed and that recurring expenditures will no longer be charged to the project. Also ensure that all related revenue is recognized and expenditures are charged to the project. Residual balances are subject to the terms and conditions of the award and ORA’s policies.
56.	Ensure the completion and submission of all Office of Research Administration (ORA) account reconciliations, as well as sponsor’s required technical financial, property, invention, etc. close-out forms (including updated financial disclosures) as appropriate.
57.	Confirm requirements for data retention, destruction and storage, per applicable regulations and sponsor requirements. Office for Human Research Protections (OHRP) US Food and Drug Administration International Conference on Harmonisation-Good Clinical Practices (ICH-GCP)
58.	Confirm that all study results have been submitted to ClinicalTrials.gov (if applicable). The initial study results are required within 12 months of achieving the last primary outcome. This may be sooner than study close-out. For assistance with ClinicalTrials.gov, contact Clinical Trial Disclosure.
59.	Per study protocol and ICF, study summary results should be disseminated to participants by the PI/delegated study staff, ideally after data interpretation has undergone peer-review.
60.	For questions, contact ORA Post-award at oraawardadmin@miami.edu

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