Human Research Training Symposium 2016

Size: px

Start display at page:

Download "Human Research Training Symposium 2016"

Kristian Heath
6 years ago
Views:

1 Human Research Training Symposium 2016 Office of Clinical Trials Administration (OCTA) Jennifer J. Ford, MBA September 6, 2016

2 Office of Clinical Trials Administration (OCTA) Purview of Services Industry Sponsor-Initiated clinical trials (for-profit sponsors) Pre Award Transactions CDA/NDA* OCTA Staff New Contract** OCTA Staff New Budget** Study Team OCTA Staff Post Award Transactions Index Setup Creation Contract Amendment* Budget Amendment* Payment Allocation Cost Transfers Approval OCTA Staff OCTA Staff Study Team OCTA Staff OCTA Staff OCTA Staff * Study Team enters request into OCTA Dashboard. ** Study Team submits through epd. 2

3 How to Start a New Study with OCTA epd Submission (training and access required) epd Clinical Trials Manual Documents required for contract finalization Any agreements provided by Sponsor Budget or Sponsor Budget Template 700U Form to COI (addendum, if applicable) IRB Approved Human Subjects Protocol IRB Approved Informed Consent Form Additional requirements Coverage Analysis (OCAA) Bulk Account Application (Velos) 3

4 Life Cycle of a New Industry Sponsor Initiated Clinical Trial CDA New Contract/ New Budget Study Activation Enroll Patients Releases protocol to PI; agreement to perform trial New contract redlined and negotiated New budget built be either OCTA or department Contract fully executed Compliance approval received Index created Study team enrolls patients per contract and protocol Amendments Negotiated as needed. Budget built by either OCTA or department Invoicing Study Team invoices Sponsor per the finalized budget terms of contract Payments Payments received by OCTA and deposited to study index Cost Transfers Study team reconciles funds Submit to OCTA on KLT template Study Inactivation Study team inactivates study with IRB; notifies OCTA to inactivate index 4

5 Confidentiality/Non-Disclosure Agreement (CDA/NDA) with OCTA A CDA/NDA is negotiated prior to Sponsor sending a protocol for PI review. Submitted to OCTA via the OCTA Dashboard. OCTA Dashboard has 6 required fields to enter a CDA/NDA request. An attachment is required to submit a request to OCTA for redline and review. CDA/NDAs are study-specific: Any UCSD employee with a legitimate "need-to-know" is covered by the executed CDA. It is not necessary to execute multiple CDAs for the same project for multiple employees. Reviewed by OCTA within 48 hours of receiving draft CDA/NDA. 5

6 New Contracts (CTA) / New Budgets with OCTA Submitted to OCTA for review via epd Ensure all required fields are completed and documentation uploaded per the epd Clinical Trials Manual Once submitted and approved, the data will automatically flow into OCTA Dashboard in the Contract Officer work queue for review and redline. The PI and Study Team should thoroughly review the contract for items such as: The payment terms for proper invoicing Confidentiality and Intellectual Property Timelines for completion of CRFs (Data) Equipment obligations Use of Biospecimens / Samples 6

7 New Budget Services with OCTA OCTA budget team ensures all costs are covered by the Sponsor New Internal Budget Template Lists all procedures, assessments, and time related effort in detail Includes a summary of all costs and a breakdown of time allocated per study team member (including time for assessments and procedures) Adhere to the latest fee structures for services such as: IRB, Indirect Costs (IDC), Research Rates, Case Rates etc. OCTA Budget Preparation fee is covered by the Sponsor PI reviews and approves budget before being finalized with a Sponsor 7

8 Amendments with OCTA Submitted to OCTA via the OCTA Dashboard Linked to existing Award OCTA Dashboard has 5 required fields Amendment attachment is required OCTA Budget Services are available Builds and negotiates the contract amendment budget Completed in parallel with contract amendment negotiations 8

9 Index Creation with OCTA Requirements for Index Creation by OCTA Contract is signed and fully executed OCTA Dashboard status is listed as active. Require approval from central compliance offices: IRB and COI Study Team is notified of index creation The study team and PI are notified via by OCTA with an electronic copy of the executed contract. Study index is created within 24 hours of receiving approvals from the central compliance offices. 9

Invoicing and Payments with OCTA Study Team is responsible for all invoicing to Sponsor For all study-related items or services as outlined in the finalized budget and payment schedule.

10 Invoicing and Payments with OCTA Study Team is responsible for all invoicing to Sponsor For all study-related items or services as outlined in the finalized budget and payment schedule. Sample invoice template available on OCTA website: Payments should be mailed to OCTA Invoice verification will be requested. Contact for check questions. Payment details available on OCTA Dashboard. 10

11 Cost Transfers with OCTA OCTA approves cost expense transfers associated with fund 79600A EPET (Electronic Payroll Expense Transfers) ENPET (Electronic Non-Payroll Expense Transfers) Expense Journals (KLT Template Only) Requirements to be approved Transfers of funds to/from 79600A MUST be made to a discretionary fund and when the study is closed. All expense transfers MUST include accurate information for transfer being done: What is the purpose of the journal (closing index, correcting error, etc..) Additional details including name and of preparer More information found at: 11

12 Electronic Proposal Development (epd) with OCTA Purpose of epd Replaces CTA Request Form. Electronic routing and approval replaces ink signatures. Repository for all proposal documents. Web-based system that allows 24/7 transparency into the record, online collaboration and remote access. epd controls access to proposal records. Training and Approval Access is required for the proposal creators (not for PIs) in order to create a new Clinical Trial proposal in epd. 12

13 Electronic Proposal Development (epd) with OCTA 13

OCTA Dashboard OCTA Dashboard Main Functions: CDA/NDA Requests and Tracking New Contracts/New Budgets (In-Process and Post Award) Amendment Requests and Tracking Check

14 OCTA Dashboard OCTA Dashboard Main Functions: CDA/NDA Requests and Tracking New Contracts/New Budgets (In-Process and Post Award) Amendment Requests and Tracking Check Reporting and Unclaimed Checks Personalized tracking for in-process and Awarded studies (for studies where the user is listed as PI, Study Coordinator, or Financial Contact). 14

15 OCTA Dashboard My Tracker 15

16 OCTA Dashboard 16

17 Questions 17

Post Award Reporting

Post Award Reporting Requirements What happens after the award is received Tamara Franklin, Assistant Controller Michelle Bremenkamp, Manager Grants & Contracts Accounting Agenda ORA/GCA main duties GCA/Department/PI