CCR Orientation Requirements
The CCR orientation includes several activities:
- review of orientation modules and SOPs
- Research orientation class
- database training
If you have any questions at anytime, please don’t hesitate to contact me at firstname.lastname@example.org or at 301.451.2179.
Elizabeth Ness, RN, MS
Director, Office of Education and Compliance
Office of the Clinical Director
Center for Cancer Research, NCI
|NCI Orientation (Federal Employees)||Two hour session in Building 31. To be arranged by the AO|
Introduction to the Responsible Conduct of Research course (one time)
Human Subjects Protection and Good Clinical Practice training: CITI Program Training (Triennial refresher required)
These courses are to be completed during the first 4 weeks of employment.
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:
NIH Technology Training
To be completed by all Investigators, Fellows, non-FTE trainees and other non-FTE scientific contributors within 3 months of start date.
|Log into the LMS home page. Search for the NIH Online Technology Transfer course which should have a "current" box next to the version. Once completed, use the navigation bar, select learning, then certifications. Print/save your certificate and send a copy to Elizabeth (Liz) Ness.|
|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
There are 10 clinical trials orientation modules which will provide a basic overview of clinical trials/research.
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 Worksheet||The 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.
|Orientation to Day Hospital|
For Research Nurses, NPs, and PAs: This 2 hour orientation will provide an overview of the Day Hospital.
Please contact Legna Hernandez to schedule. This activity needs to be completed within your first 4 weeks of employment.
NOTE: For MD Investigators, this will be included in your face-to-face class orientation.
|Integrated Research Information System (iRIS) Training||iRIS 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 10/5-1608. REGISTRATION IS REQUIRED.|
To register for one of the training classes listed below, please email Nicole Grant.
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.
NCI Telework Program: https://mynci.cancer.gov/topics/nci-telework-program
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|