Collaboration Process

Collaboration Process

1) Initial Contact and MARCH Approval

  • Interested party (site principal investigator or sponsor) contacts local MARCH site administrative contact or Jennifer Bufford, MARCH Administrative Director based at the University of Wisconsin MARCH Central Administration site, to make initial inquiry regarding a MARCH collaboration.
  • Interested party sends protocol (and budget, if available) to MARCH Central Administration personnel and confirms MARCH sites of interest for collaboration and any pre-identified investigators. MARCH Central Administration notifies MARCH administrators at each MARCH site of interest for the proposed study.
  • MARCH Central Administration personnel sends confirmation of MARCH interest, any pre-identified investigators, and protocol materials (to include budget details, if applicable) to MARCH Advisory Committee for formal vote to ensure the proposed study is feasible for implementation and is consistent with the mission of MARCH. The interested party will be informed of the vote typically within 1-3 days of making an inquiry and requesting protocol consideration.

2) Fiscal Review Processes

  • MARCH Central Administration personnel will work with the lead PI and his/her team and the local site MARCH Administrator to schedule a MARCH Fiscal Subcommittee (comprised of budgetary personnel from participating MARCH sites) conference call.
  • Lead PI or local MARCH Administrator provide proposed budget (with standardized per subject reimbursement) to MARCH Central Administration personnel for dissemination to MARCH Fiscal Subcommittee members from collaborating MARCH sites for review in advance of scheduled conference call discussion.
  • Lead site PI and his/her fiscal staff will present protocol and proposed budget and timelines for subcontracts or fee for service agreements on scheduled MARCH Fiscal Subcommittee Call.
  • After budget finalization, PI at lead site and his/her fiscal personnel work with collaborating MARCH sites to generate contracts and facilitate processing through local site sponsored programs departments.
  • Lead PI site fiscal personnel set up all post-award invoicing and oversee contracts and agreements.

3) Study Personnel and Population Identification

  • Individual MARCH site administrators assess collaborating investigator interest at each MARCH site chosen by the interested party if not already identified previously.
  • For all collaborating PIs identified, MARCH personnel at each site will also confirm appropriate study personnel (coordinator(s), administrator(s), budget and contracting personnel, etc.) for ongoing correspondence regarding study information and initiation activities.
  • If desired by the interested party, MARCH Central Administration personnel will assist with requesting feasibility and cohort analysis information from each collaborating site and disseminating any associated files for this purpose.

4) Regulatory Steps

  • If MARCH Advisory Committee approval and collaboration across at least two MARCH sites is confirmed, the lead Principal Investigator (PI) notifies his/her local IRB personnel of the proposed study and provides necessary documentation for their assessment of IRB of record options and submission recommendations. Lead site MARCH site Administrator and the PI will update MARCH Central Administration personnel when direction from lead site IRB is obtained so that this information can be communicated to other participating sites.
  • After confirmation regarding IRB review processes for the proposed study, the lead site PI will submit the protocol as directed and will confirm the submission with his/her local MARCH Administrator and MARCH Central Administration.
  • Upon IRB approval of the study, MARCH Central Administration will be notified and will subsequently send a confirmation email to all participating sites.

5) Other Preparatory Activities

After MARCH Advisory Committee approval of study, lead site PI and his/her staff, lead site MARCH personnel, and MARCH Central Administration personnel convene by teleconference and correspond via email to address trial planning activities outlined below.

  • Lead site PI confirms Clinical Trial Management System (CTMS) of choice for study.
  • MARCH Central Administration or lead site will develop source documents and CRFs, if needed, with CTMS personnel.
  • License and training documents will be requested from participating MARCH sites by MARCH Central Administration personnel or lead site personnel.
  • Lead PI and his/her study staff, lead site MARCH Administrator(s), and MARCH Central Administrative team discuss plans for:
    • Site initiation visits (SIVs) such as venue (face to face, webinar, teleconference). MARCH Central Administration personnel will generate initial draft of SIV agenda for lead PI and his/her staff to review (agenda will include protocol review by PI, GCP and ICH training; case scenarios; CRF and CTMS review and training; relevant MARCH SOP information, coordinator call schedules, etc).
    • Subject Central Registration process and site responsibility.
    • Proposed monitoring plan for the study, if applicable. MARCH Central Administration will assist with MARCH performance site communication regarding the monitoring plan and its implementation, if desired.

6) Final Steps before Study Implementation

  • Completion of SIVs with all MARCH performance sites.
  • IRB approval notice(s), consent form, HIPAA Authorization, recruitment materials, and all other IRB approved documents uploaded in CTMS for site personnel access (performed by MARCH Central Administration or lead PI site, based on preference).
  • Open the study sites to accrual in the Clinical Trials Management System (CTMS).
  • Lead PI site enters study on gov site, if applicable
  • MARCH Central Administration notifies sites that they may initiate the protocol and confirms revolving twice monthly study coordinator conference call dates

7) Ongoing Trial Activities

  • MARCH Central Administration will confirm and facilitate twice monthly research coordinator calls (Investigators may also join, if interested) and will keep investigators apprised of recruitment progress and any questions.
  • Lead MARCH site will provide MARCH Central Administration personnel with copies of all IRB of record approval information (e.g. revised protocol, consent form, safety information) for dissemination to all participating sites. These documents will be uploaded into the study CTMS by MARCH Central Administration or the lead PI site, based on preference).
  • MARCH Central Administration will assist with scheduling any PI requested conference calls (e.g. PI discussion regarding study status, recruitment best practices), if desired during the study.

Note: If proposed study is part of a federal grant application, MARCH Central Administration personnel will provide a pre-award checklist inclusive of all necessary steps (e.g. biosketch collection, enrollment tables, letters of support, etc.) for lead PI and MARCH site review for specification of task responsibilities. If proposed study is industry sponsored, MARCH Central Administration and lead site MARCH personnel will work collaboratively with chosen lead PI site to execute the steps noted above.