Clinical Research Operations

NIH Clinical Center Orientation
 Note: for nurse clinical research coordinators this needs to be completed as part of your credential packet. 

All new employees working in the NIH Clinical Center, Building 10, must complete initial training as part of their onboarding process. Institute/Center (Non-CC) new hires working in Building 10 may complete NIH Clinical Center orientation training requirements online (10 modules).

• NIH Clinical Center Patient Safety
• NIH Clinical Center Emergency Procedures for the Hospital
• NIH Clinical Center Fire Safety
• NIH Clinical Center Infection Control
• NIH Clinical Center Preventing Tuberculosis in the Workplace
• NIH Clinical Center Universal Precautions
• NIH Clinical Center Patient Confidentiality and Privacy
• NIH Clinical Center Diversity Appreciation
• NIH Clinical Center Quality Improvement
• NIH Clinical Center Service Excellence

These courses can be found in the HHS Learning Portal (LMS) at https://lms.learning.hhs.gov.

List of courses and LMS troubleshooting guide:  https://www.cc.nih.gov/owmd/pdf/CC_Online_Orientation_IC.pdf

If you attend Clinical Center (CC) Virtual orientation, you satisfy the first 7 modules. Find the last 3 modules on you New Employee Training Record and complete them in LMS.

Falls Prevention & Safe Patient Handling and Mobility- Complete via the link to the right, sign and keep for your records.
Note: for nurse clinical research coordinators this needs to be completed as part of your credential packet. 

Link to the training:

http://intranet.cc.nih.gov/nursing/training/pdf/FMF_Falls_Risk_Prevention_Strategies.pdf 

NIH Information Security Awareness for New Hires
Note: for nurse clinical research coordinators this needs to be completed as part of your credential packet. 

http://irtsectraining.nih.gov/
Log in with your HHS ID

New Employee Ethics (For Federal employees and USPHS Commissioned Corps only)
Note: for nurse clinical research coordinators this needs to be completed as part of your credential packet. 
The Ethics in Government Act requires an agency to provide an initial ethics orientation to employees new to the agency. The National Institutes of Health (NIH) provides a web-based training system in completing this requirement.

Web-based training via NIH Ethics Program

via LMS learning home page 

http://lms.learning.hhs.gov

NIH Implicit Bias - Full Course  

Note: for nurse clinical research coordinators this needs to be completed as part of your credential packet.

via LMS learning home page (Search Course number 00238076)

https://lms.learning.hhs.gov/ 

NIH Research Ethics Training: Introduction to the Responsible Conduct of Research course
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

Note: for nurse clinical research coordinators this needs to be completed as part of your credential packet. 

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

Save your certificate and email a copy to Tracy Kirby, Nurse Educator

NIH Technology Transfer Training
Course provides 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.

Note: for nurse clinical research coordinators this needs to be completed as part of your credential packet. 

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 Tracy Kirby, Nurse Educator

CITI (Collaborative Institutional Training Initiative) training:

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 (HSP) and Good Clinical Practice (GCP- US FDA Focus). You will first have the option to test out of the GCP course which requires a score of 80%. If you do not receive the passing score, you will then be directed to complete the modules. The HSP course doesn't have a test out option.

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. Once a course is completed, you will receive an email from CITI. Please forward the CITI email to Liz Ness. Also, please save a copy for records.

To be completed by all PIs, AIs, clinical research coordinators, data managers, and key research personnel.

Note: for nurse clinical research coordinators this needs to be completed as part of your credential packet. 

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

1. Click here to start navigating to the NIH CITI portal Log into your CITI account via the NIH portal. Then click on the CITI training tab to start. Please read the directions in the gray box on this website first.
2. Once you are logged in to the NIH CITI portal using your NIH log in, select NIH View Courses
3. Scroll down to Add a Course
4. Select Biomedical 101 (this is human subject protection training) and Good Clinical Practice  (US FDA Focus).
5. If you are involved with Social, Behavioral, or Education research, please complete the course Social & Behavioral Research 
6. If you will be working with children, please complete the course Vulnerable Populations - Research Involving Children.
7. If you will be working on studies that have a genetic or genomic component, please complete the course Genetic Research in Human Populations.
8. Clinical Research Coordinators (nurse and non-nurse): Please complete the CRC Foundation course. This can be done at any time, but is recommended after CCR and CRC orientation and within the first year of employment. Please click here to see the specific points in the training that are not consistent with NIH processes and policies
9. You may take any of the other courses.
10. Launch the required and any additional courses and complete
11. When you receive an email about completion with a link to your record and certificate, please forward to Liz Ness. Save a copy of your record and certificate for your files. Biomedical 101 and GCP are to be completed during the first 4 weeks of employment. Any other CITI courses may be completed later. 
12. Resource: FAQs

Credentials Verification
Process to grant authority to practice specific nursing skills and competencies after verification of credentials. Your supervisor will work with you to complete all required information and submit.

For nurse clinical research coordinators, all ten items above must be completed prior to submission.

Note:  NP/PA credentialing process is not part of this verification process. See Nurse Practitioners at NIH for details.

Credentials Verification Program

Note: Submit your application packet to your supervisor, who will submit to the Nursing Department.

Financial Disclosure Forms (For Federal employees and USPHS Commissioned Corps only)
-Updated information is due within 30 days of acquiring the new interest.
For all RNs/NPs/PAs who will be listed as an Investigator on protocols, the HHS-717-1 financial disclosure form must be completed. 

Click here: Form 717-1

The HHS-717 module is available in NEES (NIH Enterprise Ethics System).  Please log into NEES and complete the form online. You should also receive an automated NEES email prompting you to complete the requirement. The form will provide instructions. 
Note: The NIH Ethics Web site provides all ethics forms to assist employees in obtaining advance approval where required and resolve real and apparent conflicts of interest.

Admissions, Travel and Vouchers (ATV)
-One time requirement
The Admission Travel and Voucher Request System is used to request patient travel services for the NIH Clinical Center. The system receives updated information from the CRIS system once-a-day. The CRIS system will provide medical record numbers for new patients and update the ATV patient demographics records.

Web-based training via NIH Clinical Center

In addition to completing the web-based training, you will need to submit a request to gain access. Please follow the instructions found at the following website:
https://atv2.cc.nih.gov/GetAccess

Surgical Information System (SISWEB)
This is the system used for OR scheduling. However, this system is also used for patients who require anesthesia for procedures or anesthesia stand-by. To schedule, log into SISWEB and provide basic information about the case. The OR will then schedule the case.

For system training contact the scheduler at 301-496-5646 (Monday - Friday 7AM-3PM). Training will take 10-15 minutes. Users must be NIH credentialed.

SISWEB can be found at: https://sisweb.cc.nih.gov/SISWeb_PROD/  Click on the hyperlink in the box "Request Account".

Then click on the Quick Link on the right hand side "Instructions: How to Request a SISWEB-POIS User Account Access"

User Access Account Request Form to request an account must be signed by your supervisor before requesting an account. 

CRIS Training
Gain an understanding of the Clinical Research Information System (patient medical record and orders)

This is a "hands-on" training session.

Class Information

Note: Will be scheduled by employee. For RNs, this can be completed after credential verification.

Virtual/recorded course.  All new NCI employees will receive an email from the Office of Workforce Planning and Development (OWPD) with information on how to register themselves for NEO in HHS LMS. To be taken within the first 30 days upon hire. 

Independent review of NIH Clinical Center (CC) Medical Administrative Series (MAS) Policies 

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) Policies

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 Policies/Standard Operating Procedures (SOPs). 

Clinical Trials Orientation
Web Modules

     •  Good Clinical Practice and Human Subjects Protection 
     •  Clinical Trial Design 
     •  Protocol Development Review and Approval
     •  Responsibilities of the Research Team 
     •  Informed Consent
     •  Documentation and Document Management
     •  Adverse Events 
     •  Clinical Data Management
     •  Clinical Trial Monitoring and Auditing
     •  Drug Development: FDA and Sponsor Responsibilities of IND Trials

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 virtual classroom orientation.

CCR Virtual Orientation

Virtual orientation is based on your role. For content and room information, see the agenda.

For Physician Investigators (including staff clinicians): 

View two OHSRP 1 hour webinars:

Responsibilities of the Principal Investigator Part 1:  What You Need to Know & Do Before Your Protocol Starts
Responsibilities of the Principal Investigator Part 2: Implementation of a Clinical Research Protocol

Virtual Classes 2023: TBD

For ALL non-Physician Investigators, federal employees and contractors (e.g., RNs, NPs PAs, data managers, PCCs, CCR sponsor staff, post-bacs): Classroom orientation is 3 virtual classes offered 3 times a year. Please contact Liz Ness to register.

• Session 1 (virtual): March 9, 2023; March 13, 2023; March 24, 2023; See agenda for times and WebEx link; Agenda
• Session 2 (virtual): June 8, 2023; June 16, 2023; June 26, 2023. See agenda for times and WebEx link; Agenda
• Session 3 (virtual): Oct 2023 TBD

For ALL Clinical Research Coordinators (e.g., includes nurse and non-nurse clinical research coordinators): In addition to the classes above, there are additional classes offered 3 times a year. Orientation is 4 virtual classes.  

• Session 1 (virtual) For ALL Research Nurses: April 19, 2023, April 24, 2023, May 4, 2023, May 12, 2023. See agenda for times and WebEx link
• Session 2 (virtual): July 20, 2023 12p-2p, July 24, 2023 10a-12p, August 3, 2023 1p-3p, August 11, 2023 10a-12p. Agenda. 
• Session 3 (virtual): November/December 2023 TBD

The Protocol Analysis Worksheet is to be completed by all Clinical Research Coordinators (nurse and non-nurse), 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 email the worksheet to Liz Ness, who will then set up a time to meet with you and review the worksheet. This activity should 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.

For MDs, DOs, Clinical Research Coordinators, NPs, and PAs: This 2 hour orientation will provide an overview of the Adult Day Hospital on 3SE-S.

Please contact Legna Hernandez to schedule. 

PROTECT is the new electronic IRB system effective 1/17/2023

Click here for link for NIH PROTECT Training and User Guides

Clinical Database Training

There are 2 clinical databases/systems in the CCR. One is C3D (Cancer Central Clinical Database) and the other is iMedidata Rave. Training is required for both systems. C3D will be gradually phased out beginning in 2022. new studies are built in Rave and studies in C3D w ill be transitioned to RAVE starting January 2022. 

Click here for C3D to view class dates, times, locations and agenda. REGISTRATION IS REQUIRED.

Information regarding Rave new accounts, login, the user manual, quick guides for common tasks, and existing user Q&A sessions can be found here: Rave Portal - CCR Wiki (cancer.gov).

LabMatrix is a database that is typically used for biospecimen collection and results. However, some clinical content may also be collected. To schedule LabMatrix training or to work with its developers to create a database for your protocol, please contact: ncilabmatrixhelp@mail.nih.gov

Note: some protocols may use both C3D/Rave and LabMatrix.