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  • INTREPID: Project Timeline, 2014: Department of Emergency Medicine Resuscitation Research Center

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    The document outlines the project timeline and objectives for the INTREPID study from January 2014 through ongoing protocol familiarization. Key events include receiving site selection notification in January, submitting the IRB application in February, receiving IRB approval in March, conducting nurse education in March and April, and having a site initiation visit with the Neuren representative in April to review study procedures and responsibilities. Ongoing activities include coordinator training, protocol familiarization, and continued eLearning.

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    Intrepid Timeline

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    The document outlines the project timeline and objectives for the INTREPID study from January 2014 through ongoing protocol familiarization. Key events include receiving site selection notification in January, submitting the IRB application in February, receiving IRB approval in March, conducting nurse education in March and April, and having a site initiation visit with the Neuren representative in April to review study procedures and responsibilities. Ongoing activities include coordinator training, protocol familiarization, and continued eLearning.

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    Download as PDF, TXT or read online from Scribd
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    22 views3 pages

    INTREPID: Project Timeline, 2014: Department of Emergency Medicine Resuscitation Research Center

    Uploaded by

    srgauger
    The document outlines the project timeline and objectives for the INTREPID study from January 2014 through ongoing protocol familiarization. Key events include receiving site selection notification in January, submitting the IRB application in February, receiving IRB approval in March, conducting nurse education in March and April, and having a site initiation visit with the Neuren representative in April to review study procedures and responsibilities. Ongoing activities include coordinator training, protocol familiarization, and continued eLearning.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
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    of 3

    INTREPID: Project Timeline, 2014

    Medical College of Wisconsin Department of Emergency Medicine Resuscitation Research Center

    Start January 8th

    End January 8th

    Objective(s) -Site Initiation Visit -Receive Site Selection Notification Prepare IRB submission Primary Review, Modify Submission prior to Full Committee Review Full Committee IRB Review: Receive Study Approval OCRICC Meeting: Study logistics/ planning OCRICC Meeting: Study logistics/ planning NICU/NPCU Nurse Education NICU/NPCU Nurse Education Site Initiation Visit

    Method Neuren Rep. inhouse visit (see agenda, page 3) eBridge eBridge

    Resources Needed/ Enablers MCW Research Team

    January 13th Site Selection February 12th and Submission March 10th

    February 12th March 10th

    April 1st

    eBridge and Full Committee Meeting Meeting in Cancer Center (M210) Meeting in Cancer Center (K110) Live Training Live Training Neuren Representative Visit, Site Initiation Articulate Storyline, Microsoft Word Articulate Storyline Articulate Storyline

    MCW Research Team IRB Primary Reviewer, IRB Coordinator, MCW Research Team IRB Committee

    January 31st

    January 31st

    February 8th

    February 8th

    Logistics/ Planning Meetings

    March 8th March 18th April 8th

    March 8th March 18th April 9th

    MCW Research Team, OCRICC, SICU and OR staff MCW Research Team, OCRICC, NICU and NPCU, Telemetry S. Gauger S. Gauger MCW Research Team, Pharmacy, Investigators, Neuren S. Gauger

    February 25th

    February 28th

    March 3rd March 24th MCW Research Team Training

    March 21st April 4th

    Storyboard protocol training module for CRCI Module Creation Coordinator Training: Self Guided Protocol & Procedures Coordinator Q&A Site Initiation Visit

    S. Gauger S. Gauger

    April 7th April 8th

    April 7th April 9th

    Live Training Live Training

    April 10th

    Ongoing

    Continued Protocol Familiarity

    eLearning

    S. Gauger, CRC I Staff S. Gauger, MCW Research Team, Neuren S.Gauger

    Agenda for Site Evaluation Visit

    1. Introductions a. Role and prior experience with randomized clinical trials 2. Investigator discussion a. Study Overview b. Subject recruitment c. Study roles and responsibilities d. GCP guidelines i. Study oversight ii. Data confidentiality iii. Regulatory/ adverse event reporting 3. Facility review a. Off-site facilities inspection (if applicable) b. Laboratory inspection c. Pharmacy inspection d. EEG requirements 4. Local approval process a. IRB b. Clinical service agreement 5. Monitoring procedures a. Access and storage of source documents b. Monitoring schedule 6. Closure a. Define follow up plan/ action items

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