Engaged. Knowledge. Application
Clinical Monitoring CONTENT Power Package
This ninety-five (95) page package contains seventeen (17) documents for the three clinical study monitoring stages (Pre-Study, Interim and Close-out) including:
➢Three (3) SOPs
➢Three (3) Visit Reports
➢Application Guide Reference Article
➢PowerPoint Training Presentation and Trainer Instructional Notes
➢Six (6) Letters (Examples)
➢Feasibility Questionnaire
➢…and more, including:
➢1. Clinical Monitoring: GCP Compliance Application Guide (Reference Article)
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➢2. Clinical Monitoring (PDF PowerPoint Presentation)
➢3. Clinical Monitoring (Trainer Instructional Notes)
Pre-Study Phase Documents
➢4. Feasibility Questionnaire (Example)
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➢5. Pre-Study Qualification Visit Confirmation Letter (Example)
➢6. Pre-Study Qualification Visit Agenda (Example)
➢7. Investigator Site Selection and Pre-Study Qualification Visit SOP
➢8. Pre-Study Qualification Visit Follow-Up Letter (Example)
➢9. Pre-Study Qualification Visit Report (Example)
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Interim Study Phase Documents
➢10. Interim Visit Confirmation Letter (Example)
➢11. Interim Visit SOP
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➢12. Interim Visit Report (Example)
➢13. Interim Visit Follow-up Letter (Example)
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Close-Out Phase Documents
➢14. Site Close-Out Visit Confirmation Letter (Example)
➢15. Site Close-Out Visit SOP
➢16. Site Close-Out Visit Report (Example)
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➢17. Site Close-Out Follow-up Letter (Example)
1. Clinical Monitoring: GCP Compliance Application Guide (Reference Article)
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This 22 page article reviews areas of critical aspects of conducting effective clinical monitoring, including:
Clinical research environment
➢Protocol violations
➢Defining clinical monitoring
➢Clinical monitor role, functions, qualifications
➢FDA’s view on written procedures for clinical monitoring
➢Clinical investigator site selection
➢Monitoring visits, pre‐study visit, close‐out site
➢Monitoring plan, log
➢Interim monitoring
➢Access to subject records
➢Protecting subject and sponsor responsibility
➢Control of investigational product
➢Good documentation practice
➢“ALCOA”
➢Part 11 compliance and GCP
2. and 3. Clinical Monitoring (PDF PowerPoint Presentation and Trainer Instructional Notes)
Thirteen (13) slide PDF PowerPoint Training Presentation based on the subject matter presented in the Clinical Monitoring: GCP Compliance Application Guide above. This PDF ready made presentation provides “core” subject matter content, and allows you to customize specific information within your presentation.Trainer instructional notes, which contain 27 discussion points related to the PowerPoint training presentation, are also included Trainer instructional notes are designed to help focus your presentation on key points, engage attendees and encourage their participation in your training.
Pre-Study Phase Documents
4. Feasibility Questionnaire (Example)
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This seven (7) page questionnaire includes over 30 questions related to a sponsor company planning to conduct a specific study with an investigational product.
5. Pre-Study Qualification Visit Confirmation Letter (Example)
6. Pre-Study Qualification Visit Agenda (Example)
7. Investigator Site Selection and Pre-Study Qualification Visit SOP
This 10 page SOP provides written standards for the identification, qualification and selection of principal investigators/study sites for the conduct of company sponsored clinical studies, and for the conduct and documentation of a pre-study qualification visit. In the procedure section of this SOP, 55+ actions and responsibilities are specified.
8. Pre-Study Qualification Visit Follow-Up Letter (Example)
9. Pre-Study Qualification Visit Report (Example)
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This six (6) document contains sections related to:
➢Investigator/staff evaluation
➢Site information/study conduct
➢Source documentation/access to subject records
➢Storage of investigational product(s)
➢Laboratory evaluation
➢Regulatory considerations
Interim Study Phase Documents
10. Interim Visit Confirmation Letter (Example)
11. Interim Visit SOP
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This SOP provides a written standard for routine monitoring of study sites for the conduct of company-sponsored clinical studies and conduct and documentation of an Interim Visit. In the procedure section of this SOP, 55+ actions and responsibilities are specified.
12. Interim Visit Report (Example)
This six (6) page document includes sections on investigator and site personnel responsibilities and obligations
➢Protocol, protocol amendments and study-specific procedures and processes
➢Source data verification, CRF completion and data collection
➢Investigational product supplies and accountability
➢Essential and regulatory documents
➢Safety assessment and reporting
➢Study management/administration
➢…and more
13. Interim Visit Follow-up Letter (Example)
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Close-Out Phase Documents
14. Site Close-Out Visit Confirmation Letter (Example)
15. Site Close-Out Visit SOP
This nine (9) page SOP provides a written standard for theclosing of study sites participating in company-sponsored clinical studies, and for the conduct and documentation of a Site Close-Out Visit. In the procedure section of this SOP, 50+ actions and responsibilities are specified.
16. Site Close-Out Visit Report (Example)
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This six (6) page document includes sections on:
➢Investigator and site personnel responsibilities and obligations
➢Protocol, protocol amendments and study-specific procedures and processes
➢Source data verification
➢Data (CRF and data inquiries) collection
➢Investigational product supplies and accountability
➢Essential and regulatory documents/Study files
➢Safety assessment and reporting
➢Study management/Administration and discussion
➢Final closure activities
➢…and more
17. Site Close-Out Follow-up Letter (Example)
Clinical Monitoring CONTENT Power Package is only $249.00
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