CTU Bern

Data Management

The Data Management division at CTU Bern supports you depending on your requirements and level of expertize. Our services include:

Team members

eCRF Design & Database Implementation

Reporting & Visualization

User Management & Support

Overview

CTU Bern Data Management Services

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eCRF Design & DB Implementation

Full Service

 

REDCap Light

Reporting & Visualization
We set up your database in REDCap or secuTrial. You set up your database in REDCap.*

Either we or you set up your database.

Includes:

  • ✓ Hosting, license, updates, backup, and maintenance of application and server

Upon costing agreement:

  • ✓ Setup and deployment of study database: eCRFs, randomization, edit-checks, visit stucture
  • ✓ Testing of study database
  • ✓ One-time initial system training, manuals
  • ✓ Management of users, roles and sites
  • ✓ Database closure and creation of archiving package

Includes:

  • ✓ Hosting, license, updates, backup, and maintenance of application and server
  • ✓ 2h course on REDCap Database Implementation
  • ✓ Project creation
  • ✓ Templates and manuals
  • ✓ Standard role settings
  • ✓ Super user creation

Upon costing agreement:

  • ✓ Initial technical database review
  • ✓ Support during implementation
  • ✓ Randomization
  • ✓ and others

Upon costing agreement:

  • ✓ Descriptive statistics visualized in dashboards or customized reports in different formats (Markdown, Quarto, Shiny)
  • ✓ Data validation reports (Query reports)
  • ✓ Data imports including the analysis of source data, data preparation and quality check of imported data
  • ✓ Progress reports / Accrual plots
  • ✓ Support in data migration from our CDMS to yours or vice versa
  • ! *This service is only provided for members of Inselspital Bern or University of Bern
  • ! We do not recommend REDCap Light for the following scenarios: blinded studies; studies exceeding the limit of 15'000 records; studies exceeding the limit of 5'000 fields.
  • ! Please refer to our terms and conditions for responsibilities.

Full Service

Full Service: we set up your database

Consulting & Contract

  • If needed, we discuss different solutions, systems and possible collaboration
  • You provide as many study details as available (e.g. synopsis, outline, protocol, CRFs, etc.)
  • We create a costing
  • You agree and we sign a contract

eCRF Design and Database Implementation

  • Timeframe: calculate 2-4 months
  • You provide specifications as complete as possible (e.g. final codebook, study protocol, variable listing, draft case report forms)
  • We draft and test the eCRFs, edit-checks and visit structure in active and close collaboration with you
  • You test and approve the study database as in-line with your specifications

Note: Many changes/new requirements during implementation/testing may have an impact on budget and timelines

Testing

  • Timeframe: calculate 2-4 weeks
  • we perform a final review and testing
  • we discuss all findings and final settings with you
  • we prepare last steps for deployment

Deployment

  • You provide us EC approval, a list of users and sites
  • We set study database productive
  • Your database is ready to include participants!

Changes

  • You inform us as soon as an amendment is planned
  • We might do a risk analysis, depending on the complexity of the change
  • We implement and test the change in close collaboration with you
  • You test and approve the change

Note: Changes/new requirements during data collection must be planned carefully, in order to ensure that no data are lost/changed. Many changes/new requirements may have an impact on budget and timelines.

User/Site Management

  • You inform us about any changes in user, sites, roles
  • We manage user rights and roles
  • We manage sites

Closure & Archiving

  • We perform accrual closure
  • We perform database closure and archiving
  • We provide you a ZIP-file containing data and meta-data

REDCap Light

REDCap Light: you set up your own database

Consulting & Contract

  • If needed, we discuss different solutions, systems and possible collaboration
  • If you need support, we create a costing
  • If you need support, you agree on the level of support and we sign a contract

eCRF Design and Database Implementation

  • We will create a REDCap project and provide you with our template eCRFs, standard roles as well as our User Manual and useful documents, also refer to our tool kit
  • You are welcome to come to our REDCap Database Implementation Course
  • You set up your own database

 

Testing

  • You test your own database

Deployment

  • You finalise all user rights, roles, sites, etc.
  • You deploy your own database
  • We confirm deployment
  • Your database is ready to include participants!

Changes

  • You might do a risk analysis, depending on the complexity of the change
  • You implement and test the change

Note: Changes/new requirements during data collection must be planned carefully, in order to ensure that no data are lost/changed.

User/Site Management

  • We create new users
  • You manage user rights and roles
  • You manage sites

Closure & Archiving

  • You perform database closure and archiving
  • You inform us when your database is closed and archived

Support

Support

CTU Bern Data Management is available for support and requests during normal office hours (Monday to Friday from 9-17h, best via email). CTU does not offer services during nighttime, weekends or public holidays.

Refer to Status and News for planned updates and status of our systems.

Note: For running study databases, please inform us at least 1 week in advance about the creation of new study centers. The creation of new logins will take us 0-3 working days, depending on the complexity of your study and the amount of logins requested.