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Outbreak Research Data Management & ICT Aspects video

ALERRT

Outbreak Research Data Management

Outbreak Research Data Management & ICT Aspects video

Authors: Harry van Loen and Hanne Landuyt

1st June 2023

Outbreak Research Data Management & ICT Aspects video

Watch on YouTube | https://doi.org/10.48060/tghn.29

Data Management / ICT Aspects | Introduction

Section contents

A summary of Standard Operating Procedures (SOPs) | summary download

Pre-Study Phase video | PowerPoint slide download

Procedure to write, name and manage SOPs in a standardized way.
SOP-WP3-01-SOPonSOP v2.0

SOP Template v2.0
01-Attachment 01

SOPs and documents tracker v2.0
01-Attachment 02

Procedure for planning DM activities, timelines and responsibilities within a project/study.
SOP-WP3-04-Data Management Plan (DMP) v2.0

DMP Template v2.0
04-Attachment 01

General operating procedure for Data Management and IT (Project Management on DM).
SOP-WP3-05-General Operating Procedure (GOP) for DM v2.0

Example for a possible Data Manager Profile Description v2.0
05-Attachment 01

Example of DM Roles v2.0
05-Attachment 02

Example of DM Requirements Checklist v2.0
05-Attachment 03

Example of Work Breakdown Structure v2.0
05-Attachment 04

Example of DM Gantt Chart v2.0
05-Attachment 05

List of relevant DM & IT SOPs v2.0
05-Attachment 06

List of possible DM & IT Documentation v2.0
05-Attachment 07

Example of DMP v2.0
05-Attachment 08

Procedure on key aspects in paper and/or electronic Case Report Form (CRF) design.
SOP-WP3-02-CRF Design v3.0

CRF Approval Form v3.0
02-Attachment 01

Procedure of developing the database/eCRF based on the initial CRF design. (See SOP-WP3-02-CRF Design).
SOP-WP3-16-Database eCRF design v2.0

Procedure for testing of the data capture system in order to proof that the system works as planned.
SOP-WP3-17-System Validation v2.0

Validation Plan (VP) - Template v2.0
17-Attachment 01

User Requirements Specification (URS) - Template v2.0
17-Attachment 02

Functional Specification (FS) - Template v2.0
17-Attachment 03

Systems Testing Plan (STP) - Template v2.0
17-Attachment 04

User Acceptance Testing (UAT) - Template v2.0
17-Attachment 05

Installation Qualification (IQ) - Template v2.0
17-Attachment 06

Validation Report (VR) - Template v2.0
17-Attachment 07

Procedure that defines the security aspects of data capture systems (= IT systems). SOP-WP3-18-Information Security v2.0

Procedure that defines the security aspects of data capture systems (= IT systems).
SOP-WP3-18-Information Security v2.0

Procedure(s) for safeguarding the dataset (and system) during a study. SOP-WP3-19-Data Backup and Disaster Recovery v2.0

Procedure(s) for safeguarding the dataset (and system) during a study.
SOP-WP3-19-Data Backup and Disaster Recovery v2.0

Procedure for deploying a new database on the site MDC using the XML file. SOP-WP3-22-Site Database Deployment v2.0

Procedure for deploying a new database on the site MDC using the XML file.
SOP-WP3-22-Site Database Deployment v2.0

Procedure to maintain training records for Data Management (DM) & IT staff.
SOP-WP3-03-Training and Capacity Building v2.0

Training Confirmation Form v2.0
03-Attachment 01

Study Phase video | PowerPoint slide download

Procedure for capturing data on paper and/or electronic Case Report Forms (CRFs). SOP-WP3-06-Data Collection and Entry v2.0

Procedure for capturing data on paper and/or electronic Case Report Forms (CRFs).
SOP-WP3-06-Data Collection and Entry v2.0

Procedure for checking the accurateness, consistency and completeness of clinical study data. SOP-WP3-07-Data Validation and Review v2.0 Data Validation Plan (DVP) v2.0 07-Attachment 01 Data Review Log (DRL) v2.0 07-Attachment 02 Data Validation Test Plan v2.0 07-Attachment 03

Procedure for checking the accurateness, consistency and completeness of clinical study data.
SOP-WP3-07-Data Validation and Review v2.0

Data Validation Plan (DVP) v2.0
07-Attachment 01

Data Review Log (DRL) v2.0
07-Attachment 02

Data Validation Test Plan v2.0
07-Attachment 03

Procedure for keeping track of data. SOP-WP3-10-Data Tracking v2.0 Batch Cover Sheet v2.0 10-Attachment 01 Tracking Log v2.0 10-Attachment 02

Procedure for keeping track of data.
SOP-WP3-10-Data Tracking v2.0

Batch Cover Sheet v2.0
10-Attachment 01

Tracking Log v2.0
10-Attachment 02

Procedure for managing data queries during monitoring, validation, or data cleaning. SOP-WP3-21-Data Query Managment v2.0 Data Query Form v2.0 21-Attachment 01 Data Query Log v2.0 21-Attachment 02

Procedure for managing data queries during monitoring, validation, or data cleaning.
SOP-WP3-21-Data Query Managment v2.0

Data Query Form v2.0
21-Attachment 01

Data Query Log v2.0
21-Attachment 02

Procedure for data coding and coding of medical events and medications.
SOP-WP3-08-Data Coding and Medical Coding v2.0

Procedure for cross checking serious adverse events between study database and safety database.
SOP-WP3-09-SAE Reconciliation v2.0

SAE Reconciliation checklist v2.0
09-Attachment 01

Procedure that defines the security aspects of data capture systems (= IT systems). SOP-WP3-18-Information Security v2.0

Procedure that defines the security aspects of data capture systems (= IT systems).
SOP-WP3-18-Information Security v2.0

Procedure for transfer data between internal/external parties or locations (e.g. lab data). SOP-WP3-11-Data Transfer v2.0 Data Transfer Plan v2.0 11-Attachment 01 Data Transfer Log v2.0 11-Attachment 02

Procedure for transfer data between internal/external parties or locations (e.g. lab data).
SOP-WP3-11-Data Transfer v2.0

Data Transfer Plan v2.0
11-Attachment 01

Data Transfer Log v2.0
11-Attachment 02

Procedure for documenting interventions to support users on all aspects of IT and Data Management.
SOP-WP3-20-IT and Data Management Support v2.0

Procedure for upgrading the systems running on the Mobile Data Centres (MDCs) at the sites.
SOP-WP3-23-Site Systems Upgrade v2.0

Procedure for changes to network/server infrastructure or changes/updates to software or DB.
SOP-WP3-24-Change Management v2.0

Change Request Form v2.0
24-Attachment 01

Procedure to lock and unlock the study database (DB).
SOP-WP3-12-Database Lock and Unlock v2.0

Database Lock Form v2.0
12-Attachment 01

Database Unlock Form v2.0
12-Attachment 02

Post-Study Phase video | PowerPoint slide download

Procedure for archiving study data and files and to ensure regulatory requirements for retention.
SOP-WP3-13-Archiving

Procedure to describe the deviations to the DMP and to report the final status of DM aspects.
SOP-WP3-14-Data Management Report

Procedure on sharing the study data (for secondary research). SOP-WP3-15-Data Sharing

Procedure on sharing the study data (for secondary research).
SOP-WP3-15-Data Sharing

Video Data Management / ICT Aspects | Introduction

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