CITI
Program for the Protection of Human Research Subjects
Training Requirement-
VA
requires that
all
investigators, research coordinators and research assistants involved in human
studies research and all members of the Research Office, all members of the
R&D Committee, and all members and staff of the Human Studies Subcommittee,
exclusive of secretarial support, will complete annual training on both the
protection of human research subjects as well as Good Clinical Practice (GCP).
This includes off-site personnel who work with research data or samples obtained
from VA patients. Exclusions:
Clinical personnel who periodically perform tests on research patients as part
of their routine jobs and some off-site personnel (e.g. biostatisticians) do not
have to undergo the training if they do not see identifiable
data.
Procedure- (You may want to print this
page for reference.)
1.
Log into the Collaborative IRB Training Initiative (CITI)
Website
https://www.citiprogram.org/default.asp
|
If
you are a first time user:
·
Provide information
requested and proceed to the
course. |
|
If
you are reentering the site: ·
Enter your user name
and password and SUBMIT. |
2. To meet the minimum VA
training requirements for both Human Subjects Protection and Good Clinical
Practice, you must complete either the Basic modules if you have never
taken this course on the EES website or are a new
investigator.
Take the refresher course
modules, if you have taken the course before on the EES website.
3. Print the certificate of
completion the grade book or view the completed modules. Keep a copy for your
records and send a copy to Research Service- mail code #151 or send by e-mail to
colleen.murphy@va.gov.
2006 VA PRIDE Curriculum- noted on pg. 2
for Basic and Refresher courses. You need an overall 80% to pass.
Basic Modules
list:
|
Required Modules
|
|
History and Ethical
Principles |
|
Basic Institutional
Review Board (IRB) Regulations and Review Process
|
|
Informed Consent
|
|
Social and Behavioral
Research for Biomedical Researchers |
|
Records-Based Research
|
|
Genetic Research in Human
Populations |
|
Research With Protected
Populations - Vulnerable Subjects: An Overview
|
|
FDA-Regulated Research
|
|
Human Subjects Research
at the VA |
|
Conflicts of Interest in
Research Involving Human Subjects |
|
Good Research Practices
for Protection of Human Subjects, Module 3: Good Clinical Practice and VA
Research |
|
Good Research Practices
for Protection of Human Subjects, Module 5: Monitoring Subject Safety
|
|
Good Research Practices
for Protection of Human Subjects, Module 6: Records and Reports
|
|
Good Research Practices
for Protection of Human Subjects, Module 7: Managing Investigational
Products |
|
Good Research Practices
for Protection of Human Subjects, Module 8: Patient Privacy and
Confidentiality |
`
Refresher
Modules list:
|
Required
Modules |
|
101 Refresher Course -
An Overview of Research with Vulnerable Subjects(ID:
985)
|
|
101 Refresher Course -
Conducting human subjects Research at the VA(ID:
988)
|
|
101 Refresher Course -
FDA Regulated Research and Conference on Harmonization(ID:
987)
|
|
101 Refresher Course -
Genetics Research(ID: 984) |
|
101 Refresher Course -
History and Ethics(ID: 975) |
|
101 Refresher Course -
Records Based Research(ID: 983) |
|
101 Refresher Course -
Social and Behavioral Research(ID: 982) |
|
101 Refresher Course -
Informed Consent(ID: 980) |
|
101 Refresher Course -
Regulations and Process(ID: 981) |
|
GCP Update Course:
Module 1, Good Clinical Practices for VA Staff(ID:
1026)
|
|
GCP Update Course:
Module 2, Accountability(ID: 1027) |
|
GCP Update Course:
Module 3, Informed Consent(ID: 1028) |
|
GCP Update Course:
Module 4, Safety Reporting(ID: 1029) |
|
GCP Update Course:
Module 5, Documentation(ID: 1030) |
|
GCP Update Course:
Module 6, Privacy and Confidentiality(ID: 1031) |
|
GCP Update Course:
Module 7, Application of GCP Concepts(ID:
1265) |