CRP 104 Lecture 9

Question 1

challenge 1 identify potental pool and motivations

Answer 1

-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

Question 2

challenge 2 design for success

Answer 2

-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

Question 3

challenge 3 communications

Answer 3

-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

Question 4

3 types media approaches

Answer 4

-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)

Question 5

eligibility and enrollment

Answer 5

-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)

Question 6

supplies

Answer 6

-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

Question 7

pre-trial timeline

Answer 7

-feasibiliy
-trial agreement/contract
-CTA
-REB submissions
-approvals
-procedure setup (SOP, training)
-recrutiment
-screening
-drug handling
-enrollment

Question 8

during trial timeline

Answer 8

-visits
-AE/SAE
-last visit
-data entry
-analysis and reporting

Question 9

project manager definition

Answer 9

-PM, team lead for entire project, authorized to lead team and responsible for objectives

Question 10

project manager initiation

Answer 10

-high level timeline
-feasibility (finding sites - by sponsor)
-sign CTA
-budgeting
-site regulatory docs
-vendor assesment, selection and management
-investigator meeting plnning
-protocol finalization

Question 11

feasibiliy questionnaries

Answer 11

-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

Question 12

pre-study site visit (PSSV)

Answer 12

-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

Question 13

vendor assessment

Answer 13

-ensure meet requirements of study conduct
-costs of services
-contracts(outline resonsibility of sponsor and vendor)

Question 14

budget

Answer 14

-staffing
-equitment and supplies
-external vendor services (ie. labs)
-overhead/profit
-grant funds

Question 15

investigator’s meeting

Answer 15

-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

Question 16

investigator’s meeting agenda

Answer 16

-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

Question 17

Site initiation visit SIV

Answer 17

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

Question 18

site intiation visit purpose

Answer 18

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

Question 19

site initiation visit topics

Answer 19

-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)

Question 20

site initiation visit follow up

Answer 20

-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