Basic↦Documents↦Staff Documents↦Qualifications
What is it? Why is it important?
In a study, staff qualifications and ensuing responsibilities must be clearly defined and documented.
Staff qualifications and responsibilities can be documented in:
- A CV (e.g. education / further education, vocational trainings)
- Training certificates (e.g. GCP, lMP/IMD handling, data entry into the study eCRF)
- A job description, which is an agreement between employee and line manager regarding employee duties and responsibilities
- A study delegation-log, specifying staff duties and responsibilities within a given study
- An organigram, where the structural organisation of a study team is depicted, including communication and reporting lines
Depending on study design and complexity additional requirement may apply, such as:
- Selective expertise and qualifications (e.g. handling of complex machinery)
- The recruitment of external service providers (e.g. laboratories)
- The need for extensive staff trainings
What do I need to do?
As a SP-INV or Site-INV, file the following qualifying documents in the TMF and/or ISF of your study:
- Study staff CVs
- The study delegation log
- Study applicable:
- If applicable, study relevant job descriptions
Ensure CVs, training logs and job descriptions are up-to-date, personally dated and signed.
Staff expertise during study planning and conduct requires both medical and clinical expertise, including know-how regarding the special demands needed for clinical research.
More
Evaluate staff resources based on:
- Know-how:
- What type of skills are needed for the planned study?
- Does staff have the required qualifications based on education, further education, and vocational training?
- Which qualifications are missing?
- Can staff be trained or must specific study tasks be outsourced?
- Availability: Does staff have sufficient disposable free time to acquire required skills and expertise?
- Budget: How will the requirement for qualified study staff affect the overall study budget (hiring of experts, staff education and trainings)?
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
External Links
Swissethics – see in particular
- Staff list
References
ICH GCP E6(R2) – see in particular guidelines
- 2.7 Investigator’s Qualifications
- 4.1.1 Investigator’s Qualifications
- 4.1.5 List of study staff
- 5.4.1 and 5.5.1 Sponsor’s Selection
- 5.3 Medical Expertise
- 5.6.1 Investigator’s Qualifications