Effective Exam 7 Plans & Preparation Strategies
This comprehensive plan outlines the preparation timeline for Exam 7 from June 2020 to October 2021. It includes core components, study proposals, essential documents, grant submissions, and operational tasks. The schedule covers exam preparation, ancillary study proposals, grant proposal submissions, and protocol development, ensuring a structured approach to exam readiness.
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Presentation Transcript
Exam 7 Plans and Preparation June 29, 2020
Outline Outline Timeline Core Exam Components Ancillary Study Proposals
Timeline Timeline 12/20 End Yr1 12/21 End Yr2 12/22 End Yr3 12/23 End Yr4 1/21 - 10/21 Exam 7 Preparation Exam 7 Preparation 1/21 - 10/21 10/21 - 4/23 10/21 - 4/23 Exam 7 Exam 7 4/23 - 7/23 4/23 - 7/23 4/23 - 7/23 4/23 - 7/23 Close Close Close Close 1/20 4/20 7/20 10/20 1/21 4/21 7/21 10/21 1/22 4/22 7/22 10/22 1/23 4/23 7/23 10/23 1/24 4/24 7/24 10/24 12/19/2019 12/18/2024 12/19 - 8/20 12/19 - 8/20 F21 F21 8/20 - 8/21 8/20 - 8/21 F22 F22 8/21 - 8/22 8/21 - 8/22 F23 F23 8/22 - 8/23 8/22 - 8/23 F24 F24 8/23 - 8/24 F25 F25 8/23 - 8/24 1/20 4/20 7/20 10/20 1/21 4/21 7/21 10/21 1/22 4/22 7/22 10/22 1/23 4/23 7/23 10/23 1/24 4/24 7/24 10/24 12/19/2019 12/18/2024 MESA-Mind 12/19 - 4/21 MESA-Mind Visit A MESA-Mind Visit A 12/19 - 4/21 5/21 - 10/22 MESA-Mind Visit B MESA-Mind Visit B 5/21 - 10/22 1/20 4/20 7/20 10/20 1/21 4/21 7/21 10/21 1/22 4/22 7/22 10/22 1/23 4/23 7/23 10/23
Timeline Timeline 12/20 End Yr1 12/21 End Yr2 12/22 End Yr3 12/23 End Yr4 1/21 - 10/21 Exam 7 Preparation Exam 7 Preparation 1/21 - 10/21 10/21 - 4/23 10/21 - 4/23 Exam 7 Exam 7 4/23 - 7/23 Close Close Close Close 4/23 - 7/23 4/23 - 7/23 4/23 - 7/23 1/20 4/20 7/20 10/20 1/21 4/21 7/21 10/21 1/22 4/22 7/22 10/22 1/23 4/23 7/23 10/23 1/24 4/24 7/24 10/24 12/19/2019 12/18/2024 12/19 - 4/21 MESA-Mind Visit A MESA-Mind Visit A 12/19 - 4/21 5/21 - 10/22 MESA-Mind Visit B MESA-Mind Visit B 5/21 - 10/22 1/20 4/20 7/20 10/20 1/21 4/21 7/21 10/21 1/22 4/22 7/22 10/22 1/23 4/23 7/23 10/23
Timeline Timeline Exam 7 AS/Grant proposals Grant Proposals submissions Oct/Nov 2020 1st/only 2nd submissions Ancillary Study proposals submissions due August 2020
Timeline Timeline Exam 7 Prep Jan Oct 2021 Essential documents, Authorizations, Task Area B proposals/budget Protocol January March (Design Committee) Operations Manual (Clinical Operations) sIRB OSMB Review Programming Site preparation (Hiring, training, certification, ) Central Training Pilot
Timeline (suggested) Timeline (suggested)
Timeline Timeline Exam conduct 18 months Oct 19, 2021 - Apr 18, 2023 Exam Closeout 3 months Apr 19 July 18, 2023
Exam 7 Core Parameters Exam 7 Core Parameters 3,000 target Exam 7 Estimate (2022 CY) 3: WFU 475 (15.8%) 4: COL 530 (17.7%) 5: JHU 410 (13.6%) 6: UMN 505 (16.8%) 7: NWU 555 (18.6%) 8: UCLA 525 (17.6%) Total 3,000 (100%)
Exam 7 Core Parameters Exam 7 Core Parameters Emphasis on retention Suggested approach: Participant Chooses how much they want to do Complete everything possible outside of the clinic phone, online, mail, home, Total time commitment <8 hrs Core Exam ~90 minutes Ancillary studies have added ~30-90 minutes each (based on Exam 5 and 6)
Exam 7 Core components Exam 7 Core components Reception and consent Anthropometry Blood pressure Specimen collection and lab processing Blood volume 70mL total chol, glucose, A1c, creatinine, AS, QC, Repository, Spot Urine collection creatinine, albumin
Exam 7 Core components Exam 7 Core components Medical History Personal History Health and Life Medications Physical Activity FFQ/Diet?
Exam 7 Ancillary Components Exam 7 Ancillary Components MESA MESA- -MIND Visit A Visit A Anthro Anthro BP BP Questionnaires Questionnaires Medications Medications Blood Draw Blood Draw Cognitive Battery Cognitive Battery Brain MRI Brain MRI Beta Amyloid PET Beta Amyloid PET MIND Follows Exam 5 & 6 Model Ancillary Studies -> exciting science Single integrated Exam Avoid delayed or soft start MESA MESA- -MIND Visit B Visit B Cognitive Battery Cognitive Battery Brain MRI Brain MRI PET continued PET continued MIND TBD TBD TBD TBD Exam 7 Exam 7 Core Core Questionnaires Questionnaires Medications Medications Anthropometry Anthropometry Blood pressure Blood pressure Blood draw Blood draw TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD TBD
Exam 7 Ancillary Component Highlights Exam 7 Ancillary Component Highlights (Proposed) (Proposed)
