2. Training Requirements

1. Purpose

The Standard Operating Procedure (SOP) describes the processes that should be in place to ensure that each study team member who has delegated responsibilities for research studies is able to carry out these duties.

2. Application

Mandatory reading for all personnel working involved in clinical research within Starship Child Health.

3. Procedure

It is the responsibility of the Chief Investigator/Co-ordinating Investigator (CI) to confirm that the study team have received all necessary training relevant to their delegated tasks as recorded on the delegation log. If a staff member is not adequately trained in a specific area then they should not be allocated the task/s. The individual’s Curriculum Vitae will attest to task suitability and is an auditable document.

3.1 Good Clinical Practice (ICH - GCP) Training
Any staff member involved in clinical research must be GCP certified before embarking on study activities. A GCP certificate is valid for 2 years. Staff will be responsible for ensuring certification is current.

Free GCP training courses are available on line including:

• https://globalhealthtrainingcentre.tghn.org/ich-good-clinical-practice/

• https://genesisresearchservices.com/courses/investigator-and-site-personnel-good-clinical-practice-ich-gcp-training/

Face to face courses can be offered to specialties where a group of investigators wish to be certified or renew certification. Please contact starshipresearch@adhb.govt.nz for enquiries.

3.2 Study Specific Training
It is the responsibility of the CI or PI at study sites to ensure that all staff are appropriately qualified and trained, and this will be documented in the study site file. Staff members should also be familiar with the study protocol and information that is particular to their duties, and training sessions should be offered where necessary. Staff must feel confident and able to carry out specified tasks before signing the delegation log.

3.3 SOP Training
Staff must be made aware of the SOPs created for studies they are working on and a SOP record should be kept to document that staff have read and understood all relevant SOPs. Staff should be made aware of updated SOPs via email mailing list and it should be documented that new version changes have been read and understood. Updated SOPs will be version controlled and located on a shared drive location.

3.4 Training Records
Training documents for all study staff should be stored securely and easily accessible for audit and monitoring purposes. The minimum set includes;

A signed and dated CV within the last 2 years
GCP certificate
Evidence of study specific training
Evidence of SOP training
Certificates of any relevant training
Current job description

If a staff member leaves, a copy of their training record should be kept and archived by the CI with the date of leaving added to the CV. This is so they are available in the event of an audit or inspection.

4. References & Acknowledgements

International Conference on Harmonisation (ICH E6) of Good Clinical Practice https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice

HDEC Health & Disability Research Ethics Committee
https://ethics.health.govt.nz/

5. Example Format