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Study Timeline Example

The document outlines a study timeline that runs from May 2017 through November 2020. It includes activities like protocol review, IRB submission and approval, site qualifications and initiations, subject enrollment which will last until May 2019, 12 month follow-up period, database lock, clinical study report, and final study completion activities.

Uploaded by

Pamela Wolfe
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510 views1 page

Study Timeline Example

The document outlines a study timeline that runs from May 2017 through November 2020. It includes activities like protocol review, IRB submission and approval, site qualifications and initiations, subject enrollment which will last until May 2019, 12 month follow-up period, database lock, clinical study report, and final study completion activities.

Uploaded by

Pamela Wolfe
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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Study Timelines

Protocol 7/17 -
Review/Updates 7/17
IRB Submission/ 8/17 -
Protocol Approval 8/17
Discussion / 5/17 -
IRB
Site 12/17
Submissions
Qualification
9/17 -
for
CTA 2/18
investigative
Negotiations
sites 9/17 -
for
4/18
investigative
Site 11/17 -
sites
Initiations 5/18
Subject 11/17 -
Enrollment 5/19
12 Mo 11/17 -
Follow-up 5/20
Database 6/20 -
lock 8/20
Clinical Study 8/20 -
Report 10/20
11/20
Study Completion
-
activities 11/20

2017 Mar Aug 2018 Jun Nov Apr Sep Feb Jul 2020
1/1 1/1 Phase 2/2
4:
8 recruitment
Phase 2: Subject Phase 93: 0
Close-Out,
and Conduct Conduct Final Study
9/1 Report,
3/1
7
Phase 1: Negotiation Drafting
Phase 0: 7 Publication
and Initiation
Preparation and
Recruitment 1

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