Providence is committed to ensure that all individuals who perform clinical research with human participants in Spokane at Sacred Heart Medical Center & Children’s Hospital and Holy Family Hospital are appropriately qualified to perform their assigned research roles in compliance with federal regulations, Providence policies and Good Clinical Practice Guidelines.
Providence Medical Research Center coordinates a clinical research credentialing program to facilitate compliance with these requirements. Completion of the credentialing process is required prior to performing research at any local Providence facility.
Spokane Medical Research Credentialing Instructions & Requirements
You must complete and submit the following:
- Credentialing Application
- Professional License:
Any key research personnel involved in research activities are required to maintain their professional license in the health care field for their primary job/position. Current licensure documentation is required by study sponsors and institutional review boards. For example: Physician medical license (every two years), Registered Nurse license (yearly), Licensed Practical Nurse (yearly), Certified Medical Assistant (yearly), etc. Providence will verify your current licensure through the Department of Health website.
- Curriculum Vitae (CV) or Résumé (required every two years):
CVs are required by the study sponsors and IRBs prior to study start-up. They are used as initial tools for verifying qualifications, training and experience of potential study site staff from the principal investigator, sub-investigators, research nurses, research coordinators to research assistants.
CVs should include at a minimum: all medical affiliations including physically address and any research projects you were involved with during the past three years.
Frequently, sponsors will request additional “Statements of Experience” from physician investigators when conducting a study site pre-evaluation, when specific therapies/technologies are under study (E.I. carotid stenting). IRBs also require a copy of a signed and dated CV for investigators every two years. To assure current status of ongoing study staff qualifications, it is required that all CVs be signed and dated (on the first page), and a copy forwarded to Providence Medical Research Center every two years, regardless of changes to the document.
- CITI Program for Human Subjects Protection Training & Good Clinical Practice (GCP) (refresher courses required every three years):
To perform research at a Providence facility, all research personnel must complete the web-based certification program for Protection of Human Research Subjects through the Collaborative Institutional Training Initiative (CITI) Program. The purpose of the CITI program is to develop, implement and maintain a high quality web-based educational program in the protection of human subjects in research.
This is a Providence IRB-Spokane policy and the curriculum is set by the IRB. You must affiliate yourself with Providence IRB-Spokane at the time of CITI registration. Please reference the IRB website for instructions regarding the required courses.
Instructions for accessing and completing the CITI course:
- Go to the CITI website
- Click on “Register”
- Search for Providence IRB-Spokane for organization affiliation
- Follow the instructions for registration and completing the required modules
New investigators and research staff are required to complete Good Clinical Practice (GCP) training. This training is also accomplished through CITI. Researchers will use their existing CITI login and select the appropriate GCP course.
Upon completion of the required modules, print the course completion certificate for your records and attach a copy to your research credentialing application.
- Conflict of Interest in Research (COIR) training (required every three years by Providence)
Training is required prior to engaging in research and must be updated at least every three years. This is a Providence Health & Services requirement for all staff participating in clinical research to achieve compliance with the Financial Conflict of Interest (FCOI) regulation 42 CFR Part 50 and 45 CFR Part 94.
This training is also accomplished through CITI. There are four required Conflict of Interest modules.
Researchers will use their existing CITI login and must be affiliated with Providence IRB-Spokane to access the Providence-required COIR modules. COIR courses completed under a different organization affiliation will not be accepted. Print the course completion certificate for your records and attach a copy to your research credentialing application.
- COIR Disclosure
After completing the COIR training and submission of your certificate to Providence Medical Research Center, your email address will be forwarded to the Providence Compliance Office. The compliance office will send an email with login instructions for the web-based disclosure survey. Everyone involved in research must complete the disclosure form via on-line survey prior to conducting any research activities at Providence facilities. Providence requires updated disclosure within 30 days of acquiring new significant financial interest or, at a minimum, annually.
- Packaging and Shipping Hazardous Substances
For any investigator or research staff involved with processing and/or shipping bio-specimens, training is required via HealthStream to ensure proper handling and shipping. Additional training may be required if Dry Ice (Class 9 substance) is being used. Non-Providence employees may submit a copy of their employer’s “Shipping Hazardous/Bio-medical Specimen” training verification.
- Signed Research Practice Agreement:
This agreement defines basic good clinical practice and regulatory commitments to be upheld during the conduct of all research studies conducted at any Providence facility. All Investigators (principal and sub-investigators) and research coordination staff (research nurses, coordinators or assistants) are required to complete and submit the Research Practice Agreement specific to their role in research (investigator vs. research staff).
- HIPAA Training Certification
Health Insurance Portability and Accountability Act (HIPAA) training is required for all staff who will have access to subject protected health information (PHI). Providence requires a yearly refresher on HIPAA policies, for the protection of patients seen at Sacred Heart Medical Center & Children's Hospital, for as long as the research study is in-progress.
Providence Employees: This is achieved/documented during central orientation upon hire. HIPAA refresher courses will be sent via HealthStream.
Contracted employees or students from affiliated programs: HIPAA training is required at time of orientation, or at the start of practicum training. If you have not received this training, please contact your faculty advisor or Sacred Heart Education Services at 509-474-3390.
Non-Providence Employees: May submit a copy of their employer’s HIPAA training verification. If you do not have HIPAA training from your employer, Providence Medical Research Center staff will contact Sacred Heart Education Services on your behalf to have the online HIPAA training sent to you.
- Professional Certification(s) (optional):
Applicants are welcome to provide any Professional Certifications (e.g. ACRP, SoCRA, ORCA, RAC) they hold.
- DHHS Background Check
Providence will review the FDA’s “debarred, disqualified investigator lists” to verify no actions are open.
- Institutional Privileges
Providence Medical Research Center will verify all physicians and allied health professionals seeking credentialing have practicing privileges at Sacred Heart Medical Center and Holy Family Hospital, via e-Priv.
At any time, Providence Medical Research Center may request additional training, depending on the nature of the research studies individuals are involved.
If at any time you have questions, please call 509-474-4345 and ask to speak with someone about credentialing.
All completed documents may be submitted via: