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CRC Foundations - Planning Research questions with answers.
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CRC Foundations - Planning Researchquestions with answers.
Planning Research - Describe the milestones involved in the clinical trial process ANS - 1. Sponsor
contacts site, obtains confidential disclosure agreement (CDA), sends protocol and feasibility
questionnaire to site
2. Site signs CDA, reviews protocol and completes questionnaire
3. Sponsor schedules site evaluation visit
4. Site receives essential IRB docs, clinical trial agreement (CTA), study budget for review
5. Sponsor receives IRB/IEC approval from site and receives signed CTA, schedules site initiation visit
6. Site starts to recruit and consent +enroll pts and complete study procedures.
7. Sponsor conducts periodic monitoring visits, meets AE reporting requirements, and conducts site
closeout visit upon study completion
Planning Research - Identify the main elements of a clinical trial protocol ANS - A clinical trial - studying
the effects of an intervention with human subjects.
Main elements:
- inclusion/ exclusion criteria
- clear controls
- randomization to avoid selection bias
- blinding to avoid observation bias
- designating primary and secondary endpoints to prove/ disprove the study's hypothesis
Planning Research - Explain the processes related to chart review, quality assurance, and protocol
development ANS - Chart Review - previously recorded data to figure out if a site has an adequate
number of potential subjects. Or to perform retrospective analysis. (Prepatory Research)
, Quality Assurance - Done through external or internal measures. Internal measures can include a group
of CRCs monitoring each others' trials or through the organizations' clinical trials office. You can also
have audits from an independent third party. This is to ensure accuracy and validity of the results.
Protocol Development - Basic elements
- Objectives
- Scientific Background
- Trial design and goals of the study
- single or multi center, open-label, randomized and double blind,
- Inclusion and Exclusion criteria
- Procedures
- Management of AEs
- Statistical considerations for rationale for study, how data is analyzed
- Data collection and record keeping section
- Quality assurance parameters (methods)
Assurance that safety of human subjects is protected
What are some of the processes involved in drug development and medical device development? ANS -
In drug development, necessary entities must be contacted (FDA, IND) and they must review.
In medical device development, premarket review is usually required (unless it's a low risk device like a
tongue depressor). IRB and FDA will have to approve of a IDE (Investigational Device Exemption) in order
for the trial to start.
Planning Research - Describe the roles and responsibilities of key clinical research team members ANS -
Principal Investigator (PI) - responsible for all study activities at a research site and may delegate tasks to
trained team members. Main roles include leading the team, making medical decisions, providing
oversight, ensuring safety of participants, being involved or delegating the informed consent process.
Sub-Investigator (SI) - performs many of the tasks as the PI and can act as a backup. They can also be a
specialist designated to carry out protocol exams or treatments if the PI is not qualified.
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