Clinical Research Operations/CRCs

HIPAA (Privacy)

Training Resource: Protecting Patient Information HIPAA [Workday Learning]

Knowledge Link [if no Workday Learning Access]

Frequency: At start of PSOM employment and every year

Oversight: Office of Privacy

Collaborative Institutional Training Initiative (CITI Program) - Human Subjects Protection

Training Resource: CITI Protection of Human Subjects Research Training - ORA

Frequency: Prior to starting clinical research. Initial training must be established, as of April 2019, renewal of CITI training for Human Research is no longer required at Penn.

Oversight: CITI training is overseen at Penn by the Institutional Review Board. Visit the Penn IRBs page here.

Penn Clinical Research (CR) Onboarding Program

The Penn Clinical Research (CR) Onboarding Program will provide comprehensive training in accordance with Good Clinical Practices (GCP) for investigator-initiated, industry-sponsored and grant-funded clinical research. It will present best standards of practice and regulatory requirements for critical job functions of the Clinical Research Coordinator and methods for achieving these standards and requirements.

University policy (SOP401) mandates that any staff member performing function(s) related to human subjects research for which the IRB would require CITI and/or HIPAA training are required to complete the Penn CR: Onboarding and encouraged to complete the Certification Program.

NOTE: OCR’s clinical research training content provider ACRP (Association of Clinical Research Professionals) is now on Moodle Workplace. Please see this Guide on how to navigate this change once you find a course of choice in Workday@Penn Learning system.

Penn Clinical Research (CR) Certification Program

The Penn Clinical Research (CR) Certification Program is designed for Penn research staff looking to increase their knowledge of clinical research.  This will allow individuals to gain a solid foundation as they advance their careers at Penn. To be eligible for this program, you must the Penn (CR) Onboarding Program.

NOTE: This training program will no longer be available/ will be sunset , starting October 30, 2023. Penn CR Onboarding (above) is still required per SOP 401 for clinical research staff engaged in clinical research.

Training Resource: Penn Clinical Research (CR) Certification Program. This training program will no longer be available/ will be sunset , starting October 30, 2023.

 Frequency: At start of employment at Penn; prior to engaging in research and every four years. This training program will no longer be available/ will be sunset , starting October 30, 2023.

 Applies to: Anyone whom the Principal Investigator determines is responsible for the design, conduct or reporting of research. Training requirement is based on PI determination only. 

Research Technology/ Systems: 

Training Resource: Specific to each system.

Frequency: Before system use.

Applies to: Required by any Faculty or staff that needs to use the technology/ system

  • PennChart: This is the electronic medical record system.
  • PennCRMS: This is the Clinical Research Management System.
  • Penn Vault SiteVault: This is the electronic Document Management System.
  • Penn iConnect: This is the Patient Recruitment Management System.

 

Training Resource: Please refer to the Financial Conflict of Interest page on the Office of the Vice Provost for Research's website for further training instructions. 

For questions regarding FCOI, please Email coi@pobox.upenn.edu

Frequency: At start of employment at Penn; prior to engaging in research and every 4 years

Applies to: Anyone whom the Principal Investigator determines is responsible for the design, conduct or reporting of research. Training requirement is based on PI determination only.

Training Resource: PennChart Training for Research Coordinators. Ambulatory training or nurse training is required along with this training to gain access to the system.

Frequency: Before system use

Applies to: Any CRC or CRPM working on studies in PennChart

Training Resource: PennChart Training for Research Billers. Ambulatory training and Research Coordinator training are required along with this training to have the ability to perform research billing review.

Frequency: Before research billing review can be conducted

Applies to: Any CRC or CRPM involved in research review of billable services in PennChart

Training Resource: PennCTMS Training

Frequency: Before system use

Applies to anyone who is: Designated by his or her department to serve in a role requiring PennCRMS training— e.g., registering studies or managing subjects in PennCTMS.

Training Resource: Penn iConnect training

Frequency: Before system use

Applies to anyone who is: Designated by his or her department to serve in a role requiring Penn iConnect training— e.g., recruiting patients, participants, healthy volunteers, and tracking recruitment strategies.

Training Resource: PennVault training

Frequency: Before system use

Applies to anyone who is: Designated by his or her department to serve in a role requiring PennVault/ SiteVault training— e.g., managing site files or electronic regulatory binders in PennVault.