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 Data Management (DM) procedures ensure data of high quality.


Staff should be trained on:

  • Procedures on how to collect study data (e.g. blood sampling and processing procedures, participant interviews)
  • How to locate and access the source data of the study (e.g. knowledge regarding correct data source such as patient file, lab printouts)
  • Data entry procedures (e.g. correct, complete and in a timely manner)
  • Data quality requirements (e.g. quality assurance, monitoring)

What do I need to do?

As a SP-INV and Site-INV train study staff on:

  • Defined SOPs/WIs and applicable guidelines before allowing staff to perform any DM tasks
  • Ensure training is current and remains up to date during study conduct (e.g. new staff, shift in delegated responsibilities, changes / updates in DM procedures or risk control-measures)
  • Document delegated DM tasks and responsibilities in a staff delegation-log, and trainings in an applicable training-log


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.


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


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


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
  • ClinO – Clinical Trials Ordinance
  • CDMS – Clinical Data Management System
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • DM – Data Management
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor Investigator
  • WI – Working Instructions
Set-Up ↦ Data Handling ↦ Database Set-Up ↦ Training

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

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

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