Platform —> Progress

• Purchase orders (POs) accepted

• Instant course enrollment

• Track employee progress

• Customize course deadlines

• Download slides for reference throughout career

• Immediate certification upon completion

See our article on 4 ways CROs can improve their clinical research training here.

Efficient Inquiry —> Enrollment timeline

• Enroll employees same-day or next-day based on generation of the invoice and other specification requests

• An invoice will be prorated for the cost of enrollment per course, per student.

• Invoice can be paid within 1 week after enrollment in the course but must be completed before the 1st employee completion of the course

• Company-related training materials, logos, and sub-domains can be integrated into the course to allow employees to have a single portal for completion of all educational training

• Specification requests can be made within time-frame of course completion for mandatory and non-mandatory modules (SOPs, MOPs)

• Courses can be branded and are SCORM compliant for use by Learning Management Systems

ICH GCP Course Outline

• An Introduction to Clinical Research (42 slides)

• An Overview of ICH GCP (45 slides)

• Code of Federal Regulations (23 slides)

• FDA 21 CFR (32 slides)

• ICH GCP E6 Section 5 - Sponsor’s Responsibilities (56 slides)

• ICH GCP E6 Section IV - Investigator’s Responsibilities (46 slides)

• ICH GCP E6 Section IV - Informed Consent Form (46 slides)

• Reporting Responsibilities of the Investigators (49 slides)

• Ethics of Research Involving Children (46 slides)

• Ethics of Research Involving Mentally Incapacitated (35 slides)

• Ethics of Research Involving Pregnant Women and Fetuses (38 slides)

• Ethics of Research Involving Prisoners (27 slides)

• ICH GCP 5.5 Trial Management - Data Handling and Record Retention (38 slides)

• ICH GCP E6 and E2A - Adverse Events (47 slides)

• Safety of Human Subjects in Clinical Research (51 slides)

CUSTOMIZATION —> CERTIFICATION

• Accredited certificate after completion of the final exam

• Healthcare professionals can receive up to 17.5 CME credit

• Customize required, excluded, and supplemental modules

• Customize of certification and logo branding

• Certification will be provided immediately after completion stating the employee name, date of complete, and certificate ID

• Certificates are PDF downloadable and credentials are verifiable through student URL

Articles to Read for clinical research education

Case Study: Multisite RCT Research Staff Training

IMARC: Clinical Research Training Requirements

Arizona CR Workforce: Education and Development Survey

PharmOutsourcing: Training Strategy to Improve Trials

Clinical trial Tracking spreadsheet for Clinical trial training logs

Download to Use and Store in the Clinical Research and Study Training tab

Clinical Trial Training SOP Example

Regulatory Requirement ICH GCP E6(R2) File 2.8 “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).”

NIH Funded Trial Requirement: GCP training should be refreshed every 3 years; achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization; demonstrate knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants

Personal Training Log Excel Template - Clinical Trial Training Log Template

Staff Training Log Excel Template - Clinical Trial Training Log Template