TRIAL ACTIVITIES I Flashcards
three examples of appropriate support systems and tools to facilitate the conduct of the study and collection of data required by the protocol?
- trial-related documents
- computer hardware and software
- electronic patient diaries
5 examples of trial information documents
- investigator’s brochure
- informed consent forms
- adverse event or safety reporting forms
- checklists to identify and document the required steps for each of the various CT activities
- investigational supplies accountability forms to document the amount and source of IP shipped and received, the amount dispensed to subjects and the return/destruction of any unused product
5 site selection criteria that the sponsor should consider
- facilities and the equipment
- dedicated, trained, experienced study coordinator
- access to the appropriate patient population
- geographic concerns
- accessibility of the site
- reputation
- cooperation
- time and cost factors
- ability and experience of principal investigator
- honest and integrity
what can RAs do?
- regulate the conduct of CTs
- review submitted clinical data and those that conduct inspections
- in SG it is HSA
what do you look out for during investigator selection - site selection?
- ability and experience of PI
- facilities and the equipment of the site
- workload of the study team
- SOP of the site is not looked at
what are CRFs?
printed, optical or e-document, designed to record all of the protocol information to be reported to the sponsor of each CT
what is eligibility criteria and who reviews it?
patients must meet all of the inclusion criteria and none of the exclusion criteria and it is reviewed by investigator
when can CT commence?
after obtaining EC and RA approval
- MUST BE BOTH
parallel submission is allowed with how many applications to RA?
single application done by CRA.
