web viewsample case report forms, etc. ... ups & deviations/violations documentation and...
TRANSCRIPT
PROTOCOL #: FP #: WIRB #:
SOM Industry Clinical Research Planning and Implementation Guidebook
Purpose: This optional planning tool is intended as a guide to assist the study team in planning and implementing clinical research in accordance with all applicable regulations and requirements. Please contact [email protected] with any questions or for assistance.Abbreviations: ACDA = Accelerated Confidentiality Disclosure Agreement CDA / NDA = Confidentiality Disclosure Agreement, Non-Disclosure Agreement
CA = Coverage Analysis (specifies study billing compliance plan)CRC = Clinical Research Coordinator (includes Clinical Research Nurse)CRS = Clinical Research Services (Ancillary service – request services through Red-Cap)FA = Fiscal AdministratorICF = Informed Consent FormIRB = Institutional Review BoardNRAC = Nursing Research Advisory Council (nurse manager approval is required for research on nursing unit)OSP = Office of Sponsored ProgramsPI = Principal InvestigatorSOMCT = School of Medicine Clinical Trials/Clinical Research officeSub-I = Sub InvestigatorWIRB = Western Institutional Review Board
HM#: IND/IDE#: NCT#: PROTOCOL TITLE / DESCRIPTION:
PI: SPONSOR: CRC: SUB-I(S): SPONSOR CONTACT NAME: EMAIL:
PHONE: FAX:
SECONDARY CONTACT (SPONSOR/CRO): EMAIL:
PHONE: FAX:
Helpful Hints/Reminders: Initiate the feasibility assessment: http://www.medschool.vcu.edu/media/medschool/SOMFeasibilityIndustryChecklistV7.pdf Notify [email protected] to schedule the pre-study planning meeting as soon as your team decides to participate in a new
clinical research study. We are here to support you through this process. Links to relevant emails and websites are attached where indicated AND on the last page. Clinical Research Services (CRS) may be hired for Budget Negotiation, Institutional Review Board (IRB) submissions, study
coordination, and for clinical services on the CRS Unit. Contact [email protected] for more information on resources.
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Table of Contents
SECTION I SITE AND STUDY SELECTION PROCESSES
SECTION II COLLECTION OF DOCUMENTATION
SECTION III SCHOOL OF MEDICINE SUPPORT AND PROCESSES
SECTION IV INSTITUTIONAL REVIEW BOARD (IRB) SUBMISSION PROCESSES: RAMS IRB AND WESTERN IRB (WIRB)
SECTION V BUDGET DEVELOPMENT, EXECUTION AND APPROVAL PROCESS
SECTION VI INTERNAL APPROVAL SUBMISSION VIA RAM SPOT
SECTION VII ADDITIONAL SUBMISSION REQUIREMENTS FOR DEVICE STUDIES
SECTION VIII INITIATION / OPEN TO ACCRUAL
SECTION IX CLOSEOUT
SECTION X RESOURCES AND LINKS
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SECTION I: SITE AND STUDY SELECTION PROCESSES (TOP)
Order of completion for items below may vary.
Document each item as required or note NA. DATE
☐ 1. Department receives Confidentiality Disclosure Agreement (CDA) or Non-Disclosure Agreement (NDA) request from potential Sponsor
☐
2. Efficient method: CRC sends request to sponsor to use Accelerated CDA form, submits sponsor-approved Accelerated CDA to OSP via RAMS SPOT.OR: CRC submits CDA to OSP for negotiation/execution via RAMS SPOT.
Accelerated CDA links: http://www.research.vcu.edu/forms/acda_template.pdf , The OSP proposed ACDA email template is in the resource section at the end of this workbook.RAMS-SPOT Note: select “Submit Document for Review” from left menu, complete screen, & select appropriate document type when uploading the agreement. https://spot.research.vcu.edu.OSP has several Master CDA templates with certain sponsors – contact OSP RED regarding Master CDA.
☐ 3. CRC notes RAMS-SPOT CDA tracking number: <INSERT #>
☐ 4. OSP negotiates changes as needed to the CDA/NDA with the sponsor on behalf of VCU, sends to PI (copies CRC) for PI signature.
☐ 5. CRC obtains PI signature
☐ 6. CRC returns CDA/NDA with PI signature to OSP via RAMS SPOT.OSP then signs and sends for sponsor’s counter signature.
☐ 7. OSP distributes a copy of the fully executed CDA/NDA to the CRC/PI & Sponsor.
☐ 8. Sponsor sends initial study documents, participation interest message, and site selection questionnaires to PI/ CRC.
☐ 9. CRC/ PI completes and submits sponsor’s site selection forms/questionnaires.
☐ 10. Sponsor conducts site assessment phone call or visit (if required.)
☐ 11. Sponsor accepts VCU as a participating site. Sponsor sends protocol, consent, regulatory, budget, contract, & other relevant study documents to PI & CRC
☐ 12. PI/CRC conducts & documents feasibility assessment as required by SOM: http://www.medschool.vcu.edu/about/finance/researchadmin/clinicaladministration/feasibility-assessment/
☐ 13. If feasibility assessment is approved by PI & Department Chair (or designee), team documents feasibility approval & accepts the study.
☐ 14. CRC sends study documents to SOMCT to initiate a Pre-Study Planning Meeting. See SOM Externally Sponsored New Study Submission Process and Section III below.
☐ 15. SOMCT sends study to OnCore via RedCap: https://redcap.vcu.edu/rc/surveys/?s=JLXsLP8DoB
☐ 16. CRC requests verification of direct Western Institutional Review Board (WIRB) payment from Sponsor.
☐17. Sponsor confirms in writing that they will pay WIRB fees directly. Include/upload this payment confirmation with the WIRB submission.
Note: If sponsor will not pay WIRB directly, current Overhead percentage must be added in order to process payment though VCU.
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SECTION II: COLLECTION OF DOCUMENTATION (TOP)
Document each item as required or note NA. DATE
☐ Protocol/ Research Plan
☐ Investigator Brochure (IB)
☐ Sample Informed Consent Form (ICF)
☐ Sponsor Budget Template
☐ Sponsor Clinical Trial Agreement (CTA)
☐ Sponsor Primary and Secondary Contact Information
☐ CRO Primary and Secondary Contact Information
☐ Verification that sponsor will pay WIRB fees directly (see Section I)(must add overhead if WIRB fees are to be paid through VCU)
☐ Study Team Roster
☐ Study Team CVs (must be signed and dated within 1 year)
☐ Study Team Medical Licenses
☐ Study Team CITI Human Subjects Protection and GCP Certifications
☐ Lab Director CV and License
☐ Local Lab normal ranges
☐ Lab CLIA certificate(s)
☐ Lab CAP certificate(s)
☐ FP number (from OSP RAMS SPOT– see Section I) – include in header above
☐ National Clinical Trial number (NCT #) (Sponsor applies for this at clinicaltrials.gov website) https://clinicaltrials.gov/
☐ Food and Drug Administration (FDA) 1572 for investigational drug study (Note: Original signed version goes to sponsor)
☐ Sponsor Financial Disclosure Forms (Original signed version goes to sponsor)
☐ Training log
☐ Delegation of authority log
☐Other documents as applicable: Protocol signature page, lab manuals, sponsor training requirements, additional credentialing requirements, advertisements, sample case report forms, etc.
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SECTION III: SCHOOL OF MEDICINE SUPPORT AND PROCESSES (TOP)
NOTE: Pre-Study Planning Meeting is required for all clinical research studies obtaining IRB full-board or expedited approval. This includes all funding sources – Industry, Federal, Foundation, etc., & Internally supported. SOMCT oversight is not required for IRB exempt clinical research.
Document each item as required or note NA. DATE See Guidance: SOM Industry Study Activation [PDF]
☐ 1. CRC contacts [email protected] to request pre-study planning meeting as soon as the study team decides they expect to participate in a new clinical research study.
☐ 2. SOMCT sends email reply with suggested dates/times (requests study information if not sent):
☐ Protocol/Research Plan
☐ Sample Informed Consent
☐ Sponsor Budget and Contract Template
☐ Names and emails of study team members / attendees Expected attendees: SoM team, PI, CRC, FA, and others as indicated (CRS if providing support)
☐ 3. Study team replies back with availability for meeting dates/times
☐ 4. SOMCT schedules pre-study planning meeting
☐ 5. SOMCT submits study to OnCore via RedCap on behalf of the study team
☐ 6. SOMCT creates initial record in RAMS SPOT, informs study team of FP number. Note: CRS may be hired to create and manage RAMS SPOT proposal
☐ 7. SOM pre-study planning meeting is held with study team
Pre-Study Planning Meeting Agenda:
☐ Feasibility Assessment review and update.
☐ Coverage Analysis and Billing Compliance initial review and billing designations.
☐ Identification of required Ancillary Services & responsible party for ancillary request.
☐ Budget/Financial preliminary planning and discussion.
☐ Additional items as indicated
☐ 8. SOMCT sends study team (and copies applicable individuals) a summary email regarding meeting discussion, identifies outstanding action items, and responsible individuals.
☐ 9. Study team & SOMCT collaborate to finalize the Coverage Analysis (CA) & billing plan forms.
☐ 10. SOMCT sends CA billing plan to OnCore for Calendar development, review and approval.(see additional OnCore items below)
☐ 11. Responsible individual submits redcap request for each required Ancillary service (See budget section below) http://go.vcu.edu/ancillaryrequest
☐ 12. CRC completes NRAC form, reviews it with the nurse manager in charge of the area or unit, and then sends it to the Nursing Research Advisory Council (NRAC) at [email protected]
☐ 13. FA begins budget development (See additional budget items below.)
☐ 14. Responsible parties complete remaining action items as outlined in study meeting summary.
SECTION IV: INSTITUTIONAL REVIEW BOARD (IRB) SUBMISSION PROCESSES: RAMS IRB AND WIRB (TOP)
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NOTE: Study team may begin IRB process PRIOR to the SOM pre-study planning meeting. Regulatory Submission and Initial Budget Development should be conducted simultaneously. All RAMS IRB and WIRB submissions must be sent electronically. CRS may be hired to perform IRB / Regulatory submissions
Document each item as required or note NA. DATE
☐ 1. CRC makes edits to the sponsor’s sample consent (ICF) as needed (with Track Changes)
☐ 2. CRC sends redlined edited sample ICF to CRS for injury clause language review and negotiation with the sponsor: [email protected] /phone 628-1868.
(Include Sponsor Contact information in the submission to CRS & copy [email protected])
☐ 3. CRS negotiates injury-clause language with sponsor.
☐ 4. When approved, CRS sends memo and VCU injury-clause language approved ICF to study team, indicating the study may be submitted to RAMS IRB.
☐ 5. CRC prepares the study in RAMS IRB (https://irb.research.vcu.edu/) and uploads required study documents as applicable:
☐ Protocol/Research Plan
☐ Sample Informed Consent(s)
☐ Investigator Brochure
☐ WIRB payment verification
☐ Study Personnel CVs, Licenses, CITI certifications as required
☐ CRS Injury clause language approval memo
☐ Additional documents requiring IRB approval (eg. Subject Training Materials, Ads, etc.)
☐ 6. After CRC enters the study in RAMS IRB, CRC notifies the PI to review and “SUBMIT” the study to VCU IRB; link: https://irb.research.vcu.edu/
Note: VCU RAMS IRB will assess study for readiness to submit to WIRB. RAMS IRB staff, PI, and CRC communicate regarding required changes/revisions. RAMS IRB reviews and, if successful, approves study for WIRB submission. RAMS IRB notifies the PI and CRC that study may be submitted to WIRB.
☐ 7. CRC completes WIRB Connexus Submission – link: https://connexus.wirb.com/default.aspx?ClearCookies=trueandReturnUrl=%2f
☐ 8. WIRB, PI and study CRC communicate regarding required changes/revisions.
☐ 9. WIRB reviews and, if successful, approves study and related documents.
☐ 10. WIRB emails IRB approval letter and approved documents to PI and study CRC.
☐ 11. CRC forwards ALL WIRB approval documents to [email protected], copies [email protected] throughout the life of the study.
☐ 12. OnCore team uploads all IRB approvals & IRB approved documents into the OnCore system.
☐ 13. CRC forwards ALL amendments or revisions to WIRB and copies SOMCT.Note: See additional amendment information below for amendments.
SECTION V: BUDGET DEVELOPMENT, EXECUTION AND APPROVAL PROCESSES (TOP)
Study teams may begin initial budget planning (NOT submission) PRIOR to the SOM pre-study meeting. Study teams may contact [email protected] for support with budget processes.
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Regulatory Submission and Initial Budget Development should be conducted simultaneously. For information about how to best align processes in order to open to accrual within 90 days click here. If CRS is hired to negotiate budget, CRS may perform applicable CRC/FA role(s). Order of completion for items below may vary.
Document each item as required or note NA. DATE
☐ 1. CRC and PI itemize study team members’ effort/time estimates per procedures listed within the protocol, budget template, and/or CA billing plan as applicable.
☐2. CRC/FA requests Ancillary Service Pricing Agreement(s) for all sponsor-paid and/or
invoiceable research items using the centralized RedCap Ancillary Services Request form: http://www.cctr.vcu.edu/clinicalresearch/researchteams/ancillary.html
If the required service does not appear as a selection, check “OTHER” and enter the service name.
☐ 3. Ancillary department(s) sends email to CRC/FA regarding specific study and department requirements/questions. CRC/FA provides responses to Ancillary department.
☐ 4. Ancillary department provides pricing agreement with CPT codes and any required registration and/or requisition forms to CRC/FA as needed to facilitate appropriate billing with the health system.
Note: If the ancillary department does not have a specific pricing agreement, the CRC/FA may use the price verification email from the department as documentation of pricing agreement.Recommendation: Contact specific Ancillary Service directly if you have not received a reply within 1 week. For ongoing Ancillary Service problems or delays, Contact Central Ancillary Service Manager: Arthur (Art) Carpenter, CCTR Senior Financial Analyst, [email protected], 828-8237.
☐ 5. FA develops draft budget. FA sends draft internal, sponsor budget & other required documents to [email protected] for initial review & feedback. SOM guidance link:SOM Industry Study Activation [PDF]
☐ 6. SOMCT reviews & sends initial budget feedback to FA PRIOR to FA beginning negotiation with sponsor. SOMCT uploads finalized CA forms, initial approved budget & edited contract template in RAMS SPOT in order to begin congruent review of budget/contract.
☐ 7. After SOMCT initial budget approval, FA begins budget negotiations with sponsor.
☐ 8. FA conducts budget negotiations with sponsor until an agreement is reached. Request SOM support if needed. FA sends updated budget to [email protected] for final review.
☐ 9. SOMCT conducts final budget review & approves budget when all necessary revisions (if any) are included in final budget. After all required revisions are complete, SOMCT sends budget approval message to FA.
☐ 10. FA submits SOMCT approved budget to the sponsor for final sponsor approval. Consult SOMCT if any modification from approved version are made.
☐ 11. SOMCT will upload final approved budget in the RAMS SPOT Funding Proposal
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SECTION VI: INTERNAL APPROVAL SUBMISSION VIA RAM SPOT (TOP)
NOTE: If CRS is hired to negotiate the budget, CRS may also be hired to administratively assist in RAMS SPOT submission.
Document each item as required or note NA. DATE
☐ 1. SOMCT (or Department FA) creates initial record in RAMS SPOT, & informs study team of FP number. Note: CRS may be hired to create and submit RAMS SPOT proposal as noted above.
☐ 2. SOMCT will upload SOMCT approved, final, signed version of each document, as applicable, in the RAMS SPOT submission.
☐ Clinical Research Compliance Document Checklist VCU Office of Sponsored Programs http://www.research.vcu.edu/compliance_program/research_coverage.htmBilling compliance forms 1, 2, 3, 4, 6 – completed & signed, as required:
☐ 1 Coverage Analysis Screening Form
☐ 2 Coverage Analysis Qualification Form (Use Device or Non-Device form, as applicable)
☐ 3 Coverage Analysis Billing Plan Form
☐ 4 Coverage Analysis Enrollment Reporting Form
☐ 6 Coverage Analysis VCUHS Billing Set-up Form
☐ Internal Budget – approved by SOMCT, must match External (Sponsor) Budget
☐ External (Sponsor) Budget – approved by SOMCT, must match Internal Budget
☐ Clinical Trial Agreement/Contract WORD format with revised Final Payment Terms
☐ Signed Ancillary Pricing Agreements (or Pricing Verification emails) as applicable
☐ CRS Ancillary Agreement as applicable
☐ 3. FA completes review of RAMS SPOT submission and uploads any additional documentation.
☐ 4. After verifying study documentation in RAMS SPOT, PI submits proposal for approval Note: Only the PI may submit in RAMS SPOT to “Route for Approval”
☐ 5. Submission is routed to [email protected] to begin approval review process.
☐ 6. [email protected] notifies study team regarding any needed revisions.
☐ 7. Study team makes all required changes/revisions, notifies [email protected]
☐ 8. After all required changes complete, [email protected] approves submission. The submission routes to OSP via the RAMS SPOT system.
☐ 9. OSP negotiates the contract (CTA) on behalf of the University and collaborates with study team as needed. [Note: may be done concurrently with budget negotiation if study team submits appropriate documentation to initiate at time of SOM Initial Review.]
☐ 10. OSP notifies the study team & SOM when the contract is finalized and study is awarded.
☐ 11. OSP sends VCU/VCUHS billing compliance documents to VCUHS.
☐ 12. G & C Account is established for study billing.
SECTION VII: ADDITIONAL SUBMISSION REQUIREMENTS FOR DEVICE STUDIES (TOP)
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Document each item as required or note NA. DATE
☐
1. For Category A or B Investigational Devices, CMS approval must be obtained by sponsor for studies submitted to the FDA January 2015 or after.
Medicare Benefit Policy Manual Ch. 14 - Medical Devices
☐ 2. For Investigational Devices, CMS approval must be obtained by the study team for studies submitted to FDA prior to January 2015. Study team must submit to CMS for approval as required – see guidelines on Coverage Analysis form 2B. CRS may be hired to submit device study to CMS.
http://www.research.vcu.edu/compliance_program/research_coverage.htm
☐ 3. A VCUHS purchasing agreement will be required if the cost of the device exceeds standard device charges.
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SECTION VIII: STUDY INITIATION / OPEN TO ACCRUAL (TOP)
Note: Order of activities listed below may vary. CRC enters each applicable item in OnCore task-list when completed.
Document each item as required or note NA. DATE
☐ 1. Site Initiation Visit completed (Sponsor’s implementation plan), enter OnCore task-list.
☐ 2. Internal Study Initiation Items/Processes:
☐ a. Develop / Record / Follow Departmental SOPs for internal processes and plans.
☐ Protocol management plan – Develop for overall study management.
☐ Study Binder - Establish and maintain in “audit-ready” condition.
☐ Subject Binders - Establish & maintain in “audit-ready” condition.(Shadow Chart to contain source documents)
☐ Regulatory Binder - Establish and maintain in “audit-ready” condition.
☐ Regulatory Amendments from Sponsor – submission to IRB.Send all amendments to SOMCT for Coverage Analysis review & update.
☐ Regulatory process - ongoing IRB submissions. Includes Annual reviews, Safety reports, VCU Investigator changes, etc.Copy SOMCT on all IRB approvals throughout the life of the study.
☐ Contract/ budget Amendments – submission to OSP.Send all amendments to SOMCT for Coverage Analysis review & update.
☐ Subject recruitment planIncludes Pre-screening, Screening log, ICF log, enrollment tracking plan, etc.
☐ Subject management plan.Includes Source Documents, Study orders, Checklists, etc.
☐ Clinic scheduling planIncludes process for scheduling / registering participants.
☐ Subject data collection processes.
☐ AEs, SAEs, UPs & Deviations/Violations Documentation and Reporting plans.
☐ VCUHS - MCVP Billing plan / processes.Account and Billing plan have been established
☐ Other items as indicated.
☐ b. Training - Provide study information & document training to personnel as needed.All study team members, ancillary service providers, clinics, nurse managers, etc. must have been trained and be ready to participate.
Training log – Completed and signed as required, enter OnCore task-list
☐ c. Roles & Responsibilities Communicated and documented.Delegation of Authority log - Completed & signed as required, enter OnCore task-list
☐ d. Investigational medication and/or device received from sponsor, enter OnCore task-list.
☐ e. Sponsor Approval to begin enrollment has been received by study team, enter OnCore task-list.
☐ 3. OnCore Management and OnCore Open to Enrollment: Verify that all needed approvals are in place and documented in OnCore.
DATE
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Note: Oncore Management is required after team has been on-boarded to use OnCore system.
☐ a. Protocol record has been created in OnCore.
☐ b. Calendar has been developed by OnCore team; Calendar has been reviewed, revised as needed & approved by CRC, enter OnCore task-list.
☐ c. OSP has awarded study G & C Accounting / Index number (to charge expenses) has been created & documented in OnCore.
☐ d. OnCore CRC task-list has been completed by CRC
☐ e. OnCore Administrative approval has been completed by SOMCT
☐ f. OnCore Open to Accrual has been completed by OnCore team
☐ 4. Subject enrollment and management plan:
☐ a. Recruit, enroll, manage and monitor subjects according to protocol and all research compliant guidelines.
☐ b. Submit all safety reports, AEs, SAEs, UPs and deviations/violations as required.
☐ c. Enter subject and calendar information into OnCore.
☐ d. Send updated Enrollment Log for each new enrollment and each study visit to:VCUHS Billing: [email protected] – Not required when subjects are managed in OnCore.
☐ e. Manage study billing as outlined in billing compliance documents, budget & contract.
☐ f. Manage protocol deviations/violations as required.
g. Manage protocol billing as required.
☐ h. Enter subject data into Case Report Form (CRF) as required by protocol & sponsor.
☐ i. Notify SOMCT of all on-going IRB approvals.
☐ j. Notify SOMCT of all study amendments and revisions to protocol, consent, budget, contract, etc.
☐ k. Maintain all study documents, records & binders in “Audit Ready” condition.
☐ l. Coordinate monitoring visits, audits, follow-up and close-out activities as required.
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SECTION IX: STUDY CLOSEOUT (TOP)
Document each item as required or note NA. DATE
☐ 1. Sponsor close-out:
☐ a. Data transmission
☐ b. Timelines
☐ c. Final data verification
☐ d. Drug disposition
☐ e. Storage requirements
☐ f. Closeout visit
☐ g. Return of sponsor-owned devices/ equipment
☐ 2. Local VCU close-out:
☐ a. Regulatory (IRB)
☐ b. Administrative (OSP, Investigational Pharmacy, other as applicable)
☐ c. Financial (G & C)
☐ i. All expected participant bills have been received and paid by the study.
☐ ii. All PI, Coordinator, and other study staff time/effort has been appropriately charged to the study.
☐ iii. Sponsor has been invoiced for all items due.
☐ iv. All revenue due from the sponsor has been received.
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SECTION X: CLINICAL RESEARCH RESOURCES AND LINKS (TOP)
SOMCT Ongoing and Follow-up Support
Please contact [email protected] with suggestions, questions or for assistance: Coverage Analysis / Billing Grid development support, sign-off, and revisions/amendments Clinical Research Compliance Forms OnCore protocol submission, study management and subject entry Budget Development/Guidance/Negotiation Internal and External Budget items Miscellaneous clinical research items as needed. SOM Coordinator training and on-boarding
Visit our SOMCT website for these and additional clinical research links: http://www.medschool.vcu.edu/about/finance/researchadmin/clinicaladministration/
VCU Clinical Research Links.
VCU School of Medicine Clinical Research Administration:http://www.medschool.vcu.edu/about/finance/researchadmin/clinicaladministration/
VCU Office of Research and Innovation Integrity and Compliancehttp://www.research.vcu.edu/integrity_compliance/
OnCore Wiki:https://wiki.vcu.edu/display/oncore/VCU+Oncore+Wiki
OnCore loginhttps://oncoreapp.mcvh-vcu.edu/login/
CRS Wiki: https://wiki.vcu.edu/display/CCRA/Centralized+Clinical+Research+Administration+Home
VCU Coordinator Councilhttp://www.cctr.vcu.edu/clinicalresearch/corner/council.html
VCU Office of Sponsored Programs (OSP):http://www.research.vcu.edu/osp/
VPRI Compliance notices:https://wiki.vcu.edu/display/ResearchCompliance/OVPRI+Research+Compliance+Notices
VCU RAMS Institutional Review Board (RAMS IRB):http://www.research.vcu.edu/human_research/rams_irb.htm
External Clinical Research Links Western Institutional Review Board (WIRB): https://connexus.wirb.com/default.aspx?ClearCookies=trueandReturnUrl=%2f Clinical Trials. Gov Website:
https://clinicaltrials.gov/ Centers for Medicare and Medicaid Services (CMS) Medicare Administrative Contractors (MAC) Palmetto:
http://www.palmettogba.com/palmetto/providers.nsf/DocsCat/Jurisdiction-11-Part-B~8EELD83717
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Accelerated CDA template link: http://www.research.vcu.edu/forms/acda_template.pdf
OSP Proposed email template for Accelerated CDA:
Virginia Commonwealth University (VCU) has adopted the use of the Accelerated Confidential Disclosure Agreement (ACDA) template. This template was developed by Clinical and Translational Science Award (CTSA) recipient institutions and partnering industry sponsors as a mechanism to streamline the negotiation process between institutions and industry with the goal of reducing contracting delays thereby enabling researchers to obtain study protocols in a timely manner for evaluation of their inclusion as a site in potential industry-sponsored clinical trials. The attached ACDA template is provided for execution in lieu of negotiation of the sponsor confidentiality template. As a registered user of the ACDA, VCU has agreed that use of the term Accelerated Confidential Disclosure Agreement or ACDA is only permitted when referring to the unmodified template. Any changes made to the template by the Sponsor shall require review and negotiation by the Office of Sponsored Programs (OSP) and negates the use of the ACDA template as is.If you agree to use this template in its unmodified format, please fill in the appropriate study and contact information, sign and return and VCU will move forward with full execution of this agreement. Please refer any questions regarding the use of the ACDA to the VCU Office of Sponsored Programs (OSP), Industry and Clinical Trials. OSP may be reached by email at [email protected] or by phone at 804-828-6772.Thank you for supporting this important initiative.
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