What is it? Why is it important?

Study staff represent personnel that contribute to the implementation of a study.

 

Main study staff supporting the:

 

Study staff must be qualified by education, training and experience. This is documented in:

  • A site organigram: structural and organisational relationships
  • CV: education, continuous education, job experience

 

The delegation of study tasks can only take place after study relevant trainings which include:

More

Staff trainings should be done:

  • By qualified trainer(s) or through self-training
  • On site, by phone or web-based
  • Both at study initiation and during study conduct
  • Prior to performing any training required study delegated task
  • Upon changes of study relevant documents (e.g. study protocol, the ICF, SOPs)
  • Upon change of study relevant staff or delegated responsibilities

 

Upon training, the trainer and trainee date and sign the training log. By signing, the trainee confirms to have read and understood the content of the given training.

What do I need to do?

As a SP-INV and Site-INV, select appropriately qualified staff based on:

  • Study specific requirements
  • Staff qualifications (e.g. education, experience)

 

Establish:

  • A staff management folder that includes staff education, job description and trainings (e.g. CV, job description signed by staff and line manager, ICH-GCP, ISO trainings).
  • Training logs for study relevant trainings (e.g. informed consent process, study protocol and its amendments, safety, SOPs, WIs, risk-control measures)
  • A study site delegation-log which documents the delegation of study tasks and responsibilities

 

Ensure staff qualification and training documents remain up-to-date and are personally signed and dated.

More

On the training log, always refer to type of document(s), material(s) or other aid(s) used during training, (e.g. include name of document, validation date, and version number).

 

As documents are subject to ongoing changes, version or release dates are adapted accordingly. Only by including document details, can it be guaranteed that staff received the appropriate training(s).

 

Required study specific qualifications may include but are not limited to:

  • Project management
  • Study coordination
  • Safety and risk management
  • Statistics and methodology
  • Various medical examination and analysis
  • Handling of data and electronic data capture
  • Handling of biological material and analysis

Where can I get help?

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

External Links

Swissethics – see in particular

  • Information on professional qualifications
  • List of persons conducting a study

References

ICH GCP E6(R2) – see in particular guidelines

  • 4 Site-INV responsibilities
  • 5 SP-INV responsibilities

ISO 14155:2020 Medical devices - see in particular sections (access liable to costs)

  • 9 Responsibilities of the sponsor (SP-INV)
  • 10 Responsibilities of the principal investigator (Site-INV)

Swiss Law

ClinO – see in particular article

  • Art. 6 Professional qualifications

HRO – see in particular article

  • Art. 4 Professional qualifications
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • CV – Curriculum Vitae
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ICF – Informed Consent Form
  • ISO – International Organization for Standardization
  • SOP – Standard Operating Procedures
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Development ↦ Management ↦ Responsibilities ↦ Staff Qualification and Training
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
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
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 Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Responsibilities ↦ Staff Qualification and Training

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