Admit | Association for Data Management In the Tropics

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SOP’s

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Work Packages
  • SOP's
  • System Landscape
  • Data Review
  • OSRS
  • CDISC/CDASH
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  • GIS/GPS
  • HDSS
  • DHIS2
Publications
  • ECTMIH 2011
  • EDCTP 2011
  • ASTMH 2014
  • ECTMIH 2015
  • EDCTP 2018

SOP’s

After predefining a list of essential DM processes, the members of the network each prepared two SOPs which were presented and reviewed during the 2nd ADMIT workshop, December 2011. A harmonisation process ensured uniform structure across the SOPs.

The alignment of the individual processes provided an overall lifecycle for DM in clinical research.

DM Life Cycle ADMIT

Documents only available to members.
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001 SOP General Data Management

001 Template Requirements Checklist

002 SOP CRF design

003 SOP eCRF Design

003 Example Data Dictionary

004 SOP System Validation

004 Template User Requirement Specs

004 Template Installation Qualification

004 Template IQ Retest

004 Template Operation Qualification

004 Template OQ Retest

004 Template Perform Qualification

004 Template Validation Report

004 Template Change Control

005 SOP Information Security

005 Template Information Asset

005 Example Confidentiality & Conduct

006 SOP Training

006 Template Training confirmation

007 SOP Data Management Plan

007 Template DM Plan

008 SOP Data Collection & Data Entry

009 SOP Data Cleaning

009 Template Data Clarification Form

009 Example Data Clarification Form

010 SOP Data Coding

011 SOP SAE Reconciliation

011 Template SAE Reconciliation Check

012 SOP Data Tracking

012 Template-Batch-cover

012 Template Tracking Log Template

013 SOP-Database-Lock

013 Template Dbase Lock Check

013 Template Dbase Lock Approval

013 Template Dbase Unlock Approval

Supported by

Institute of Tropical Medicine

Antwerp, Belgium

(This initiative) has been supported by Clinical Research Network project (Project 1.28)
of the DGD-ITM Framework Agreement sponsored by the Belgian Directorate-General for Development.

© 2021 Institute of Tropical Medicine