Some clinical research staff want to advance their careers by becoming certified. Resources can be found on this tab that may be helpful in studying for certification exams.
Recommended books to study for certification exams
A Comprehensive and Practical Guide to Clinical Trials (eBook)
Focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members.
Conducting Clinical Research (eBook)
This is a step-by-step how-to manual for both experienced medical professionals and novices looking to enter the field of clinical studies.
Fundamentals of Clinical Trials
Textbook on clinical trials methodology, this book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol.
The CRA's Guide to Monitoring Clinical Research
Location: Eskind Biomedical Library
Reference Collection
Call Number: QV771 W396 2019
Protecting Study Volunteers in Research
Location: Eskind Biomedical Library
Call Number: W32.5 AA1 D923p 2012
The Sourcebook for Clinical Research (book has been ordered)
An actionable, step-by-step guide through beginning to advanced topics in clinical research.
US Federal Regulations (21 CFR)
Other Regulations and Websites
Regulations and Guidelines
- Belmont Reportethical principles and guidelines for the protection of human subjects of research
- Clinical Investigators Conducting Therapeutic Clinical Trials Handbookexplains the policies and implementing procedures for the conduct of
therapeutic clinical trials sponsored by the Division of Cancer Treatment and Diagnosis
(DCTD), National Cancer Institute (NCI) - Declaration of Helsinkiethical principles for medical research involving human subjects, including research on identifiable human material and data
- E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)encourages implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The guidance is intended to improve clinical trial quality and efficiency, while maintaining human subject protection and reliability of trial results.
- Guidance for Industry E6 Good Clinical Practice: Consolidated Guidancethis guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.the principles established in this guidance may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects
- ICH E2A Clinical safety data management: definitions and standards for expedited reportingthe development of standard definitions and terminology for key aspects of clinical
safety reporting, and the appropriate mechanism for handling expedited (rapid) reporting, in the
investigational (i.e., pre-approval) phase - Nuremberg Codeset of research ethics principles for human experimentation
Websites
Adult-Gerontology Nurse Practitioner Certification Intensive ReviewLimited to 3 users at a time
Family nurse practitioner certification intensive reviewLimited to 3 users at a time
Midwifery & women's health nurse practitioner : certification review guideLimited to 3 users at a time
Pediatric Nurse Practitioner Certification Review Guide: Primary Carelimited to 3 users at a time
Information Sheets
Self Assessment Options
There are many quizzes on these sites. Terms such as “ACRP”, “SoCRA”, “ICH GCP”, “CCRP”, “CCRC”, “ethics in research”,” 46 CFR 46”, and “protecting human research”, among others, can be used to help find quizzes.
CRAM: cram.com
Course Hero: coursehero.com
Quizlet: quizlet.com
Online Training
- Collaborative Institutional Training Initiative (CITI Program)trusted standard in research, ethics, and compliance training
- Good Clinical Practice (GCP) Courseprepares research staff in the conduct of clinical trials with human participants
- Office of Research Integrity and the Office for Human Research ProtectionsThe Research Clinic: interactive training video educates clinical and social researchers on the importance of appropriately protecting research participants and avoiding research misconduct.
- VUMC Learning Exchangesearch for the module "HRPP Basic Module"
RAND Institute GCPS Flashcards
Clinical Research staff can use good clinical practices made easy cards to help study federal regulations and concepts to prepare to take certification exams.
Instructions for access
Employees may check out the flashcards at the Eskind Library front desk.
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Checkout time limit for the flashcards is a 2 hours with the option to extend
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Flashcards are in house use only and must remain at EBL
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Please be mindful and considerate of other employee’s time for the flashcards
