Delegation & Training
This role is ultimately responsible for ensuring all study staff are trained and qualified.
Who is the PI?
Documents which individually and collectively permit the evaluation of the conduct of a trial and the quality of the data.
What are essential documents?
What are source documents?
The following group needs to approve all new guidance documents and SOPs prior to dissemination.
What is the SOP & Guidance Committee?
Monitors must enter CHCO through this entrance.
What is the CHCO main hospital entrance?
Personnel operating within their scope of practice during the trial are not required to be on this document.
What is the DOA log?
Any unforeseen event/information that causes harm or increased risk to participants.
What is a UAP?
The acronym for the key principles of data integrity in clinical trials.
What is ALCOA+?
This type of document can be shared externally upon receiving approval.
What is an SOP?
This role is responsible for maintaining monitoring reports in the ISF.
Who is the regulatory specialist?
These team members are not required to complete training despite being listed on the DOA log.
Who is the regulatory specialist?
This form is required for IND studies.
What is an FDA 1572?
A study team member may perform the consent process without an interpreter if they have this certification.
Who is a Qualified Bilingual Staff?
This feature in Florence displays the entire modification history for a document.
What is the audit trail?
These two forms must be completed by the study monitor prior to the monitoring visit.
What are the Limited Work Force Training & Orientation Forms & the Non-Employee Security User Agreements?
This should be sent to all active study team members on the DOA within 5 days of IRB-approval.
What is protocol amendment training?
If a PI's leave of absence exceeds this length of time, a formal change in PI must occur.
What is more than 6 months?
Documents that do NOT require this are disseminated as FYI emails by the lead CRC on a study.
What is IRB approval?
The required time range that study records must be stored onsite after IRB-closure of a trial.
What is 3-6 months?
Site cannot perform any other study work after closure from this body.
Who is the IRB of record?
This approval must be received prior to starting internal processes for a change in PIs for industry trials.
What is Sponsor approval?
Sponsor should be notified of a change in this role, but no revisions will be made to the site FDA 1572.
Who is a sub-investigator?
This individual is required during the consent process when a short form is used in place of fully translated ICF.
Who is a witness?
Following 10-year study closure, documentation here will be moved to long-term archive.
What is Florence?
A monitor may request to come onsite with less than 2 weeks notice for this type of visit.
What is a milestone-based visit?