First version

This includes ensuring the trial is conducted in accordance with the protocol, trial specific procedures, local regulations and Good Clinical Practice guidelines. 

Trial planning

Prior to sponsors  trial application in CTIS the PI  must ensure that the trial is properly anchored in the institution and provide an updated curriculum vitae (CV) and complete declaration of interest. The PI must provide completed Site Suitability, issued by an institution representative. The function of the institution representative should be described in a local procedure and is usually the head of department or clinic. The Site Suitability describes the site’s ability to conduct the actual trial in respect to  using the investigational medicinal products, facilities, equipment and human resources. Sponsor should specify trial specific requirements to be included, e.g. required equipment etc before sending the form to PI. If the site cannot fully meet all requirements or foresee additional risks due to e.g. patient population or logistics, the principal investigator should clearly inform the sponsor.

The PI must provide  validation documentation for electronic source data systems and other electronic systems deployed by the institution for the trial  e.g. DIPS.   The sponsor should ensure that the relevant electronic source data systems have been assessed and considered as fit for purpose

Prior to trial start a site initiation visit will be done by sponsor’s monitor. PI and relevant trial staff must be present at the site initiation visit. When all major findings are resolved and sponsor has signed off the report, the site monitor will issue “green light” allowing the site to start recruiting participants.

The following must be in place prior to trial start and may be done as part of the initiation visit:

• Documented delegation of tasks
  • The tasks should be performed by qualified personnel., see Training and Qualification – SOP 1.7 a. The personnel should either be listed on a delegation log or there should be an agreement for internal service providers or a contract for external service providers. Agreements/contract with service providers should specify that defects/deviations identified should be reported to the principal investigator. These should then be reported to the sponsor. See Agreements, Information Routines and Delegation of tasks – SOP 1.13.a.

• Overview of source data
  • The sponsor should provide a source data list that the PI completes.

Trial follow-up

The principal investigator is responsible for the oversight of the trial at site which includes (but is not limited to):

• Recruitment and timelines

• New trial personnel/service providers:
  • See paragraph “Documented delegation of tasks”, see section Trial planning above
  • Change of PI needs to be approved by authorities and the approval may take up to 3 months, or even longer if application is delayed due to ongoing trial applications in the system. It is therefore crucial that the sponsor is informed of planned changes. The sponsor should also be informed about other changes in central site personnel such as study nurses to have proper oversight
  • In trials where the sponsor has approval to transfer trial tasks to local hospitals/treatment facilities, agreements must then be signed between the trial site and the local hospital. Sponsor should pre-approve the agreements and sponsor’s procedures should be followed

• Informed consent process
  • The informed consent process should comply with the protocol. The “Informed consent and patient recruitment procedure” that the sponsor has gotten approved by authorities might give complementary information. See also SOP Obtaining Informed Consent

• SAEs and other safety concerns
  • PI must have knowledge of SAEs and other important medical events, even if the visits are performed and documented by delegated site staff

• Deviations
  • Record and report to sponsor deviations to protocol or legislation from site and service providers
  • Implement corrective and preventive action as appropriate 

• Trial data capture
  • The data source recording should comply with the source data list
  • The recording of data into the eCRF should be timely and correct
  • The data should be signed off by an investigator. To do that the investigator should have a thorough knowledge about the dataflow e.g. what data are direct transcriptions from the medical records or other records and which data need to be assessed and signed for before being finalised.

• Investigator site file (ISF)
  • The ISF should be up to date
  • See SOP Study Files and SOP Completion, Reporting and Archiving

• Risks
  • The principal investigator should inform the sponsor about new identified risks that may negatively affect the participants or the data quality  

• Monitoring reports
  • The principal investigator should ensure that the findings in the monitoring reports/follow-up letters are acted upon within given timelines

• Agreements
  • The principal investigator should ensure that commitments described in agreements with, e.g. sponsor and service providers are complied with

For documentation of tasks performed Checklist Conduct of Clinical Trial – Center  and Checklist Completion of Clinical Trial – Center  can be used.

Download:

• Checklist Conduct of Clinical Trial Centre – Template
• Checklist Completion of Clinical Trial Centre - Template
• Investigator Curriculum Vitae - Template
• Declaration of Interest - Template
• Site Suitability - Template