Site Journey
What comes right after Feasibility in the site journey?
SSV (Site Selection Visit)
What are the main activities during Study Start-Up, broadly?
FQ, SSV, SIV
During SIV, can a CRA train site staff on the protocol?
Yes protocol walkthrough/training is a core part of SIV
Is a CV (investigator's curriculum vitae) an Essential Document?
Yes CVs are listed among ICH-GCP Essential Documents; they prove investigator qualification
What does eTMF stand for?
electronic Trial Master File
Name one thing checked about a Principal Investigator's qualifications during SSV.
Any of: their CV, medical license, or GCP training status.
"What are the main activities during Close-Out, broadly?
IP Reconcilation, resolving EDC queries, completion of documents.
During a monitoring visit, can a CRA correct a source document error directly in the patient's medical record?
No a CRA can identify and flag discrepancies (via SDV), but only site staff can correct their own source records, with the correction properly documented
Is a staff training record an Essential Document?
Yes it demonstrates staff were qualified to perform their delegated tasks
True or False: A protocol deviation only needs to be logged if it affects patient safety.
False anything that doesn't match the approved protocol must be logged regardless of impact
The signal that a site is cleared to begin enrollment
Green light
What happens during the Maintenance Phase?
ongoing SMV/RMV monitoring, continuous IP accountability checks, AE/SAE review, protocol deviation tracking, action item follow-up, and ongoing eTMF filing
Can a CRA sign the informed consent form on behalf of the site?
No only the PI or an eDOA-authorized site staff member can obtain/sign consent; the CRA's role is to verify the process was followed, not perform it
Is IRB/EC approval an Essential Document?
Yes one of the most fundamental Essential Documents; a trial cannot proceed without it on file
Why are Essential Documents required, in one sentence?
Per ICH-GCP, they individually and collectively permit evaluation of how a trial was conducted and whether the resulting data can be trusted
In real-world practice, which usually takes longer: negotiating and signing the site contract, or actually running the SIV training day itself?
CTA. Site contract and budget negotiation is consistently the slowest real-world step in getting a site activated — often taking weeks to months — while the SIV itself is usually just a single day once everything else is finally in place.
“Facility walkthrough of exam rooms and pharmacy” happens on SSV. True or False: this same walkthrough is repeated again at SIV.
False SSV confirms capability BEFORE selection; SIV doesn't re-walk the facility, it trains staff on protocol/consent/IP now that the site is already selected and Green Lit
During SIV, a CRA notices a coordinator isn't yet on the eDOA, but she's scheduled to help with the very next subject visit. Can the CRA allow this?
No anyone performing trial-related tasks must be listed and delegated on the eDOA BEFORE performing those tasks; she cannot participate until she's added
Is a patient's prescription (IP dispensing record) a Source Document or an Essential Document?
Primarily a SOURCE Document it's the original record of what happened to the patient; it supports, but isn't itself formally listed among, the standard Essential Documents like drug accountability logs
If a CRA visits a site but never writes up a report afterward, does that visit still "count" as having happened?
No as far as anyone reviewing the trial later is concerned, a visit with no report basically didn't happen. PMs learn this fast the first time a client asks for proof that monitoring took place and the paperwork simply isn't there.
Put these in correct order: SIV, Green Light, SCV, SSV, SMV/RMV.
SSV → Green Light → SIV → SMV/RMV → SCV
Which checklist would “AE/SAE reporting process reviewed” appear on, and which would “Essential documents complete & filed in eTMF” appear on?
AE/SAE reporting process reviewed → SIV; Essential documents filed in eTMF → SCV
True or False: A CRA can grant Green Light approval on their own authority if the checklist looks complete.
False Green Light is signed off by the Sponsor/CRO Clinical Operations lead (often jointly with Regulatory/QA), not the CRA alone; the CRA supports and verifies but doesn't have unilateral sign-off authority
Name ONE document that is BOTH a Source Document AND an Essential Document at the same time, and explain why it qualifies as both.
The signed Informed Consent Form it's a SOURCE document (the original record that consent was given, signed and dated by the subject) AND it's explicitly listed as an ICH-GCP Essential Document
Can a CRA physically administer the study drug to a patient during an SMV?
No a CRA's job during SMV is to review and verify what happened, never to actually treat the patient. Only qualified, delegated site staff (the PI or authorized nurse) can administer the drug.