Skip to end of metadata
Go to start of metadata

CCR Orientation Requirements

The CCR orientation includes several activities:

  • review of orientation modules and SOPs
  • Research orientation class (offered 4x/year)
  • database training

If you have any questions at anytime, please don’t hesitate to contact me at nesse@mail.nih.gov or at 301.451.2179.

Thank you,
Elizabeth Ness, RN, MS
Director, Office of Education and Compliance
Office of the Clinical Director
Center for Cancer Research, NCI

Orientation Activity

Teaching Strategy

 NCI OrientationTwo hour session in Building 31. To be arranged by the AO

Introduction to the Responsible Conduct of Research course (one time)
This module assists investigators to understand when they are engaged in human subjects research, and when review by an IRB or a determination by OHSRP(regarding the need for IRB review) is required before research may commence.

To be completed by all incoming Intramural Research Program (IRP) Investigators

https://researchethics.od.nih.gov/

Human Subjects Protection and Good Clinical Practice training: CITI Program Training (Triennial refresher required)
CCR requires that all clinical research staff take the CITI training courses for both human subjects protection and good clinical practice (PI or non-PI). Modules take 20-30 minutes to complete. You will first have the option to test out of the the Biomedical 101 & GCP courses which requires a score of 80%. If you do not recieve the passing score, you will then be directed to complete the modules.

If you cannot complete training in one session, just complete the current module and return to the course at a later time. You will need to score an 80% for each module quiz in order to receive a Certificate of Completion for each module. Please remember to print to a pdf your certificates, and send via email to Liz Ness. Also, please save a copy for records.

To be completed by all PIs, AIs, research nurses, data mangers, and key research personnel.

Please review and follow the steps below to access the correct training courses:

  1. Go to: http://ohsr.od.nih.gov/  and sign by clicking: Human Research Protection Program (NIH login required)
  2. Scroll down to Required HRPP Training (bottom of 1st column)
  3. Scroll down to Clinical Research Staff
  4. Click on the Clinical Research Staff link.
  5. Scroll down to the Training Links and click on CITI Courses
  6. Select one of following options (first time users or returning users):
    1. If you have taken CITI courses through NIH before click here.
    2. If this is your first time taking CITI courses through NIH click here.
  7. Select NIH courses
  8. Select Add a Course or Update Learner Groups
  9. Select Biomedical 101 (this is human subject protection training) and GCP (for non-PI or PI).
  10. If you will be working with children, please take the optional course Vulnerable Populations - Children.
  11. If you will be working on studies that have a genetic or genomic component, please take the optional course Genetic Research in Human Populations.
  12. You may take any of the other optional courses.
  13. Launch the required and any additional courses and complete
  14. Once completed, go to the “my reports” section on the top menu bar and select “My Reports”. Print the page to adobe PDF, save PDF.
    1. Retain one copy for your records

    2. Send one copy to Elizabeth (Liz) Ness

These courses are to be completed during the first 4 weeks of employment.

NIH Technology Training
Course provided information related to the various types of agreements used with collaborators including material transfer agreements (MTAs), Clinical Trial Agreements (CTAs) and Cooperative Research and Development Agreements (CRADAs).

 

To be completed by all Investigators, Fellows, non-FTE trainees and other non-FTE scientific contributors within 3 months of start date.

 NIH Online Technology Transfer (via the LMS home page)
Safe Shipping and Handling of Infectious and Biological Substances
-Every 2-3 years, depending on where shipping to (i.e., U.S. or international)
One-day classes for all personnel involved in the shipping of infectious substances, diagnostic specimens, biological specimens and dry ice classified as "dangerous goods." Limited space is available in each class.

To register for a class, please visit the following website: https://www.safetytraining.nih.gov
Independent review of NIH Clinical Center (CC) Policies (Medical Administrative Series)

Review the NIH CC Policies: http://cc-internal.cc.nih.gov/policies/list_policies.asp?index=med_sub. Note: this site requires using an NIH computer to access.

Independent review of the NIH Intramural Research Program (IRP) Human Research Protection Program (HRPP) SOPs

Review the current NIH IRP SOPs for human subjects protection: https://federation.nih.gov/ohsr/nih/pnp.php. Note: NIH log-in required.

Independent review of CCR SOPs and related forms

Review the current CCR SOPs for clinical research from the CCR homepage for Clinical Research Operations: CCR Standard Operating Procedures. Click on 'CCR SOPs and Related Forms'.

Clinical Trials Orientation
Web Modules

There are 10 clinical trials orientation modules which will provide a basic overview of clinical trials/research.

The course is be completed during the first 6 weeks of employment or prior to the classroom orientation.

Classroom Orientation

For Physician Investigators: Clinical trial orientation will consist of 2 half-day classes offered quarterly. Click here to visit the series website and for information on how to registers.

For Research Nurses, Data Managers, NPs, PAs, Regulatory/Protocol Specialists: The 1.5 day Clinical Trial Orientation series is offered quarterly. Click here to visit the series website and information on how to register.

For Patient Care Coordinators: The half day Clinical Trial Orientation class will be offered quarterly. Click here to visit the series website and for information on how to register.  

Note: You must complete the above clinical trials orientation web modules as a pre-requisite for the classes.

Protocol Analysis WorksheetThe Protocol Analysis Worksheet is to be completed by all Research Nurses, NPs, PAs, Clinical Data Managers, and any other staff members who would like to do so. Select a protocol that you will be working with, complete the worksheet, and then give the worksheet to Liz Ness, who will then set up a time to meet with you and review the worksheet. This activity needs to be completed within the first 4 weeks of employment.

Note: Clinical Data Managers will have the review done by a member of the DM team lead.
Integrated Research Information System (iRIS) TrainingiRIS is a Web-based application designed to help create, manage and process research protocols. This is the application used for scientific and IRB review of all CCR protocols. Training if offered every 2 months from 9:30 AM - 11:30 AM in room 10/3-1608. REGISTRATION IS REQUIRED.

To register for one of the training classes listed below, please email Nicole Grant.

    • January 5, 2018
    • March 2, 2018
    • May 4, 2018
    • July 13, 2018
    • September 14, 2018
    • November 2, 2018

C3D and J-Review Training

C3D (Cancer Central Clinical Database) is the central database (i.e., electronic case report forms) used for the majority of CCR clinical trials.

Click here to view class dates, times, locations and agenda. REGISTRATION IS REQUIRED.

Telework

NCI Telework Program: https://mynci.cancer.gov/topics/nci-telework-program

Review policy: https://mynci.cancer.gov/sites/mynci.cancer.gov/files/field/file/NCI%20Telework%20Program%20Policy.pdf.

Discuss telework capablity with supervisor. If cleared to telework, complete training: https://hr.od.nih.gov/workingatnih/telework/training.htm.

Complete telework agreement in ETS: https://telework.nci.nih.gov/ets/ProcessSteps.action.

Accessing shared drives remotely Review and request remote access: https://ncs.cancer.gov/basic-services/network-access/nci-remote-apps 

 

 

Last updated by Ness, Elizabeth (NIH/NCI) [E] on Dec 13, 2017