Data Management / ICT Aspects
An introduction to ALERRT and its 7 Work Packages, the Data Management Plan, the Data Management Processes with reference to the 3 Study Phases.
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A summary of Standard Operating Procedures (SOPs) | Summary download
Pre-Study Phase | powerpoint slide download
| SOP-WP3-01-SOPonSOP v2.0 Procedure to write, name and manage SOPs in a standardized way. 01-Attachment 01 SOP Template v2.0 01-Attachment 02 SOPs and documents tracker v2.0 SOP-WP3-04-Data Management Plan (DMP) v2.0 Procedure for planning DM activities, timelines and responsibilities within a project/study. 04-Attachment 01 DMP Template v2.0 SOP-WP3-05-General Operating Procedure (GOP) for DM v2.0 General operating procedure for Data Management and IT (Project Management on DM). 05-Attachment 01 Example for a possible Data Manager Profile Description v2.0 05-Attachment 02 Example of DM Roles v2.0 05-Attachment 03 Example of DM Requirements Checklist v2.0 05-Attachment 04 Example of Work Breakdown Structure v2.0 05-Attachment 05 Example of DM Gantt Chart v2.0 05-Attachment 06 List of relevant DM & IT SOPs v2.0 05-Attachment 07 List of possible DM & IT Documentation v2.0 05-Attachment 08 Example of DMP v2.0 |
| SOP-WP3-02-CRF Design v3.0 Procedure on key aspects in paper and/or electronic Case Report Form (CRF) design. 02-Attachment 01 CRF Approval Form v3.0 |
| SOP-WP3-16-Database eCRF design v2.0 Procedure of developing the database/eCRF based on the initial CRF design. (See SOP-WP3-02-CRF Design). |
| SOP-WP3-17-System Validation v2.0 Procedure for testing of the data capture system in order to proof that the system works as planned. 17-Attachment 01 Validation Plan (VP) - Template v2.0 17-Attachment 02 User Requirements Specification (URS) - Template v2.0 17-Attachment 03 Functional Specification (FS) - Template v2.0 17-Attachment 04 Systems Testing Plan (STP) - Template v2.0 17-Attachment 05 User Acceptance Testing (UAT) - Template v2.0 17-Attachment 06 Installation Qualification (IQ) - Template v2.0 17-Attachment 07 Validation Report (VR) - Template v2.0 |
| SOP-WP3-18-Information Security v2.0 Procedure that defines the security aspects of data capture systems (= IT systems). |
| SOP-WP3-19-Data Backup and Disaster Recovery v2.0 Procedure(s) for safeguarding the dataset (and system) during a study. |
| SOP-WP3-22-Site Database Deployment v2.0 Procedure for deploying a new database on the site MDC using the XML file. |
| SOP-WP3-03-Training and Capacity Building v2.0 Procedure to maintain training records for Data Management (DM) & IT staff. 03-Attachment 01 Training Confirmation Form v2.0 |
Study Phase | powerpoint slide download
| SOP-WP3-06-Data Collection and Entry v2.0 Procedure for capturing data on paper and/or electronic Case Report Forms (CRFs). |
| SOP-WP3-07-Data Validation and Review v2.0 Procedure for checking the accurateness, consistency and completeness of clinical study data. 07-Attachment 01 Data Validation Plan (DVP) v2.0 07-Attachment 02 Data Review Log (DRL) v2.0 07-Attachment 03 Data Validation Test Plan v2.0 |
| SOP-WP3-10-Data Tracking v2.0 Procedure for keeping track of data. 10-Attachment 01 Batch Cover Sheet v2.0 10-Attachment 02 Tracking Log v2.0 |
| SOP-WP3-21-Data Query Managment v2.0 Procedure for managing data queries during monitoring, validation, or data cleaning. 21-Attachment 01 Data Query Form v2.0 21-Attachment 02 Data Query Log v2.0 |
| SOP-WP3-08-Data Coding and Medical Coding v2.0 Procedure for data coding and coding of medical events and medications. |
| SOP-WP3-09-SAE Reconciliation v2.0 Procedure for cross checking serious adverse events between study database and safety database. 09-Attachment 01 SAE Reconciliation checklist v2.0 |
| SOP-WP3-18-Information Security v2.0 Procedure that defines the security aspects of data capture systems (= IT systems). |
| SOP-WP3-11-Data Transfer v2.0 Procedure for transfer data between internal/external parties or locations (e.g. Lab data). 11-Attachment 01 Data Transfer Plan v2.0 11-Attachment 02 Data Transfer Log v2.0 |
| SOP-WP3-20-IT and Data Management Support v2.0 Procedure for documenting interventions to support users on all aspects of IT and Data Management. SOP-WP3-23-Site Systems Upgrade v2.0 Procedure for upgrading the systems running on the Mobile Data Centres (MDCs) at the sites. |
| SOP-WP3-24-Change Management v2.0 Procedure for changes to network/server infrastructure or changes/updates to software or DB. 24-Attachment 01 Change Request Form v2.0 |
| SOP-WP3-12-Database Lock and Unlock v2.0 Procedure to lock and unlock the study database (DB). 12-Attachment 01 Database Lock Form v2.0 12-Attachment 02 Database Unlock Form v2.0 |
Post-Study Phase | powerpoint slide download
| SOP-WP3-13-Archiving Procedure for archiving study data and files and to ensure regulatory requirements for retention. |
| SOP-WP3-14-Data Management Report Procedure to describe the deviations to the DMP and to report the final status of DM aspects. |
| SOP-WP3-15-Data Sharing Procedure on sharing the study data (for secondary research). |
