EDT-001 CCTS Enterprise Data Trust (EDT) Procedure: Training and Documentation Requirements for Obtaining Access [Researchers and IPOP/EDT Staff]

Draft Date: August 31, 2011 Version 1

Approval Date: 11/28/11 V1

Revision Date(s): 2/13/14 V7, 1/14/14 V6, 8/21/12 V5, 5/25/12 V4, 4/25/12 V3, 1/9/12 V2

Revision Approval Date: 3/7/14 Version 8 [supersedes previous version]

How Do Researchers Gain Access to the Data in the CCTS Enterprise Data Trust?

Access Request Application: Researchers will request access to the i2b2 tool to generate queries on aggregate patient counts or for a dataset to be pulled from the EDT via an online service request followed by an EDT Access Application housed within REDCap. Verification of training and documentation of assurances, agreements, and approvals can be uploaded to the application online.

Training and Documentation Requirements: The access request application will require verification of a data use agreement signed by the researcher, training certificates, and a HIPAA compliance assurance form signed by the researcher. For research that falls outside of the EDT IRB approval, individual approval documents are required to be attached to the EDT Access Application for verification prior to release of data.

Completion of training is required for the researcher in each of the following areas:

1.  IRB approved human subject protection training for biomedical investigators (CITI, Dunn & Chadwick, etc.)- 3 year renewal required.

2.  UKHealthcare web based training for new hires in HIPAA Compliance-annual refresher is required.

3.  UKHealthcare Safety web based training for new hires in Corporate Compliance Module which includes Information Technology Security. This course must be repeated in compliance with the Office of Corporate Compliance/HIPAA Privacy Officer’s standards. Annual refresher is required.

Signed Documentation of Agreement by the researcher in each of the following areas:

1.  Data Use Agreement- completed with each data pull request and with i2b2 tool access request.

2.  HIPAA Compliance Assurance Form- completed with each data pull request and with i2b2 tool access request.

Mandatory Training for Human Subject Protection

To register to take Human Subject Protection training through the CITI website, click on this link: https://www.citiprogram.org/default.asp. Your certification is valid for three years. After that you will need to take a refresher course every three years to stay current.

The following registration page will appear:

CITI Login and Registration Page

/ The CITI Program is a subscription service providing research ethics education to all members of the research community. To participate fully, learners must be affiliated with a CITI participating organization.
The CITI course is a protected site. If you are a new learner at a participating organization you must register to create your own username and password and gain access to the site.
Top of Form
/ Already Registered?Login Below
Username
Password
Bottom of Form
To ensure that all users enjoy rapid response times, access is temporarily limited to 1500 concurrent users. As learners log off others will be permitted to log on. There are currently 250 users logged in to the site.
Notice: The CITI Course site is best viewed with Microsoft Internet Explorer ver. 5.0 or later or Firefox ver. 1.5 or later.
Registration Instructions:
1.  Click on the register here link in blue.
2.  Select University of Kentucky for your participating institution. This ensures that your certificate is sent to UK’s Office of Research Integrity automatically. Ignore the drop down boxes for the Veterans Affairs, Department of Energy, and the HIV/AIDS Network Coordination.
3.  Create a username using letter, numbers, and symbols 4-50 characters in length.
4.  Create a password using only letters and numbers 8-12 characters in length.
5.  Enter your name and email address. Your name should be entered the same as you want it to appear on your certificate. ORI must be able to match you to any Internal Review Board paperwork. Your email address will be used to supply a forgotten username or password.
6.  Submit your request.
7.  Go back to https://www.citiprogram.org/default.asp and log on using your username and password you just created.
8.  Once you have logged on, select your learner group. Group 1, Basic course: Biomedical Investigators and Key Personnel Research.
Group 1: Biomedical Investigators and Key Personnel
Introduction / Required
History & Ethical Principles / Required
Basic Institutional Review Board (IRB) Regulations and Review Process / Required
Informed Consent / Required
Records-Based Research / Required
Genetic Research in Human Populations / Required
Research With Protected Populations - Vulnerable Subjects: An Overview / Required
Vulnerable Subjects - Research with Prisoners / Required
Vulnerable Subjects - Research Involving Minors / Required
Vulnerable Subjects - Research Involving Pregnant Women & Fetuses in Utero / Required
FDA-Regulated Research / Required
Conflict of Interest in Human Subjects Research / Required
University of Kentucky / Required
9.  Once all of your exams are complete, you should print out a copy for your own records, or save in PDF format. You can log on at any time to print or save a certificate.
10.  Attach certificate to the access request application.
If you have trouble registering or logging on to take the exam, it may be because of limitations placed on the website. Only 1500 persons are allowed on at the same time. You may try again later. It will usually tell you how many users are logged on at any given time. Mid morning is usually the busiest time.
If you need assistance, please contact the Office of Research Integrity at 859-257-9428.

Human Subject Protection Mandatory Education Refresher

Your certification is valid for three years. After that you will need to take a refresher course every three years to stay current. According to ORIs policies, acceptable refresher courses for human subject protection training include the following:

1.  The web based CITI human subject’s protection training (refresher course option). Enter the CITI website and register as a UK user. The course is a synopsis of the main biomedical or social/behavioral modules that are required as initial training. For registration instructions refer to http://www.research.uky.edu/ori/ORIForms/42-CITI_instructions.pdf Course web address: https://www.citiprogram.org/default.asp

2.  The web based VA Good Clinical Practice and Human Subjects Protection modules (submit certificate to ORI at completion) Web address: https://www.citiprogram.org/default.asp

3.  If you attend the UK annual conference (Schulman) on human subjects protection, and have a certificate from that training, it will satisfy the requirement.

4.  If you have attended a human subjects protection program (ex. PRIM&R) within the last six (6) months, and have a certificate from that training, it may satisfy the requirement (this does not include an isolated session on human subjects protection as part of a conference on another subject matter).

5.  The web based NIH human subjects protection program (only qualifies as a refresher course and not for initial human subject protection training). Web address: http://phrp.nihtraining.com/users/login.php

6.  Register and attend selectively identified UK ORI conferences (to be announced).

Contacts:

For questions on how to satisfy the human subjects’ protection requirement, please contact Helene Lake-Bullock at Ph: (859)257-9428 or email . In addition you may contact Belinda Smith at Ph: (859)323-2446 or email .

To complete HIPAA Training for UK Healthcare

All staff can access HIPAA web-based training modules (WBT) onthe SAP- LSO system. A refresher course must be completed annually. HIPAA New Hire Training -- general training for all staff employed in UKHealthcare. Content Topics: Definition of HIPAA, Components and Regulations of HIPAA, Consequences of Non-Compliance and Reporting Problems.

1.  Log into your myUK account.

2.  Click Employee Self-Service tab. External Learners will only have the Training Center tab.

3.  Click on Training

4.  Click Course catalog> UK Healthcare > UK Healthcare Web Based Training

5.  Click HIPAA New Hire WBT or if applicable, complete the annual refresher for that year (2014 HIPAA Refresher).

6.  Book this course

7.  If you have any issues booking the course, contact IT Support at 218-HELP.

8.  Click Start course now

9.  Review materials and complete the quiz.

10.  Quiz results- Please make sure you have clicked the “log off” button or your training will not be recorded as complete.

11.  EDT will log into SAP and verify that you have completed this training. You do not have to upload anything for this into the Access Application.

Annual Refresher Required

For questions or problems with completing web based training on myUK, please contact the IT Support help desk at 218-HELP.

To complete Corporate Compliance Training for UK Healthcare

All staff can access UKHealthCare web-based training modules (WBT) on the SAP-LSO system. This course must be repeated in compliance with the Office of Corporate Compliance/HIPAA Privacy Officer’s standards. A refresher course must be completed annually. This course will introduce you to business compliance and informational technology security at UKHealthCare.

1. Log into your myUK account.

2. Click Employee Self-Service tab. External Learners will only have the Training Center tab.

3. Click Training

4. Click Course catalog> UK Healthcare > UK HealthCare Safety WBT (Web Based Training)

5.  Click UK HealthCare Safety WBT 2014

6.  Click 2014 Corporate Compliance WBT

7.  Book this course.

8.  Click Start this course now.

9.  If you have any issues booking the course, contact IT Support at 218-HELP.

10.  Review material and sign the Corporate Compliance agreement by completing the test. Click start test.

11.  Please make sure you have clicked the “Log off” button or your training will not be recorded as complete.

12.  EDT will log into SAP and verify that you have completed this training. You do not have to upload anything for this into the Access Application.

For questions or problems with completing web based training on myUK, please contact the IT Support help desk at 218-HELP.

Version 8 March 7, 2014 Page 5