What is it? Why is it important?

It is essential to guarantee that study data is collected and documented according to specifications given in the study protocol. In addition, compliance to study relevant SOPs and WIs addressing DM procedures ensure data of high quality.

Staff should be trained based on:

  • Means by which source data is collected (e.g. correct blood sampling and processing)
  • Collection of raw data (e.g. knowledge regarding correct data source)
  • Data entry procedures into the study database
  • Ongoing data quality checks and monitoring

More

In the event that participants are asked to enter data in a CRF, be it paper or electronic, they should receive appropriate training on how to do so. Both compliance as well as data quality is directly related to how well participant were trained on data collection and documentation procedures.

What do I need to do?

Train study staff on:

  • Defined DM SOPs/WIs and applicable guidelines before performing any DM delegated tasks
  • Implemented risk control measures needed to protect ongoing data quality

Ensure training is current and up to date (e.g. new staff, shift in delegated responsibilities, changes / updates in DM procedures or risk control measures)

For more information refer to Quality and Risk and Monitoring in this Trial Guide.

More

Training should be done:

  • Prior to performing study delegated tasks
  • By a qualified trainer or if manageable through self-training
  • Either on-site, face-to-face, by telephone or other applicable mean
  • During study initiation and repeated during study conduct especially in the event of poor compliance
  • Whenever necessary and before changes to study conduct (e.g. novel staff, major changes of CDMS)

Both trainer and trainee date and sign the training log. By signing, the trainee confirms with his/her signature to have read and understood its content.

On the training log always refer to type of documents trained (e.g. SOPs, guidelines). Include document name, date, and version number.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guidelines

  • 2.8 Training
  • 5.5. Trial Management, data handling, and record-keeping

Swiss Law

ClinO – see in particular article

  • Art. 6 Professional qualifications

HRO – see in particular article

  • Art. 4. Professional qualifications
Abbreviations
  • CDMS – Clinical Data Management System
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • DM – Data Management
  • SOP – Standard Operating Procedures
  • WI – Working Instructions
Set-Up ↦ Data Handling ↦ Database ↦ Training
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Set-Up ↦ Data Handling ↦ Database ↦ Training

Please note: the Easy-GCS tool is currently under construction.