CRP 104 Lecture 9 Flashcards
challenge 1 identify potental pool and motivations
-demographics, location, values and influences, culture, religion, social drivers, research experience
-subject motivations (monetary, treatement, advance research, community benefits, societial benefits)
-low doses, less clinic visits, less side effects
-location of clinic
-reduce expenses
challenge 2 design for success
-protocol recruiting strats
-does exclusion crietiera have unnesscary points?
-are timelines reasonable for pop and eligibility process?
-competition between sites for participants, keep tabs on other trials, use a registry system to authenticate your study to pool
-keep relationships with pool alive, do not delay process longer than neccessary
-remote screening, flexible study schedule, home visits
challenge 3 communications
-branding: ads, staff interactions, written docs
-all subject material must be approved by REB (ads, scripts)
-sponsor may want to approve as well
-some locations such as hospitals and schools have review boards for ads
-informed consent begins with advertisment
-not unduly coercive or promise a cure beyond the protocol
-cannot caim drug is safe or effective for the purpose of the trial
-must be clear it is investigational
-no “free medical treatement”
-do not emphasize payment
3 types media approaches
-direct (candidate meets some of criteria from the star, i.e. in a clinic specific to the condition of interest,phone databases,physician recruitment)
-semi-direct (targets candiates based on generic criteria, demographics, specific magazines, websites, peer referral, social media ads)
-indirect (wide spread targeting of potential candidates, newspaper, subway ad, social media)
eligibility and enrollment
-may need follow up with ineligble subject (failed blood test, medical care)
-all subject need to know eligibility status
-enrollment defintion varies, could be signing of ICF, randomization, dosing, etc
-assesments and enrollment must be documented
-changes to eligibilty must be documented, and subject re-assessed using protcol criteria (ie stoping criteria)
supplies
-labratory supplies, subject supplies (diary, thermometer), general (gloves, masks, batteries), equipment.
-need to know where supplies will come from, how many, how long to receive, budget, list of supplies
-inventory of supplies, issues of concern (delivery, expiry)
-place orders in advance of running out
-budget issues
pre-trial timeline
-feasibiliy
-trial agreement/contract
-CTA
-REB submissions
-approvals
-procedure setup (SOP, training)
-recrutiment
-screening
-drug handling
-enrollment
during trial timeline
-visits
-AE/SAE
-last visit
-data entry
-analysis and reporting
project manager definition
-PM, team lead for entire project, authorized to lead team and responsible for objectives
project manager initiation
-high level timeline
-feasibility (finding sites - by sponsor)
-sign CTA
-budgeting
-site regulatory docs
-vendor assesment, selection and management
-investigator meeting plnning
-protocol finalization
feasibiliy questionnaries
-for potential sites
-staffing, experienced staff
-experience with population, popuation pool size, past success at recruitment
-SOPs
-facilites and equiptment
-regulatory inspections in past, critical findings
-professional reputation(publications, (teaching) hospitals, clinics)
-location and accessibility
-interest
pre-study site visit (PSSV)
-assess site facility and research staff to ensure suitabiltity with protcol
-tour of facilites
-current copies of staff CV and GCP training
-documentation for experience with patient recruitment within protocol timeframe
-patient identificationand recruitment strats
-discuss protocol and concerns of site
-completing trials
-review/obtain site SOPs
vendor assessment
-ensure meet requirements of study conduct
-costs of services
-contracts(outline resonsibility of sponsor and vendor)
budget
-staffing
-equitment and supplies
-external vendor services (ie. labs)
-overhead/profit
-grant funds
investigator’s meeting
-finalize protcol, procdures
-standardize study conduct
-minimize site differences
-train personnel
-outstanding questions to answer
-investigator’s teams, study managers, monitors, medical/clinical/regulatory experts, QA all attend
investigator’s meeting agenda
-sponsor (background/rationale, protocol, timelines, procedures, CRFs and source docs, SAE reporting, study forms, product accountability, speciment handling and shipping, monitoring, communications, GCP training)
-investigators (protocol, proceudre, document input, study feasibility, patient recruitment, networking)
-study coordinators (procedures, CRF, patient recruitment input, practical aspects for conduction, ask questions)
-investigators must agree on study endpoint, AE reporting, and clinical practices
Site initiation visit SIV
meeting held at investigator site prior to start of CT to discuss all aspects and delegation
-need protocol, ICF, CTA, REB approval, contracts and budget, CVs, QIU, medical licenses, financial disclosure, CTSI, IP shipped, all done before meeting can take place
site intiation visit purpose
PI and staff understand responsibility, protocol, CRFs, record management/retention, drug handling, enrollment and consent, AE reporting, idenitfy problems/concerns
-PI/subinvestigators, coordinators, technicians, nurses, pharmacists, data manager,sponsor representative
site initiation visit topics
-regulatory obligations of PI and sponsor
-protocol and procedures
-randomization and blinding
-IP accountability and logs
-AE and SAE reporting
-source documents
-CRFs
-regulatory binder
-other logs
-major tasks and resonsibility
-signatures for study delegation logs
-pharmacy/site tour
-sponsor expecations (enrollment, source doc, CRFs,monitoring, specimens storage/collection/shipment)
-regulatory expectations (investigator, REB, consent, AEs)
site initiation visit follow up
-meet with investigator to discuss issues
-sonsor writes SIV report and sends to site for ISF filing (essential doc)
-sponsor follows up issues with site
