Institutional Training Requirements for Personnel Involved with Conducting Clinical Trials
The Institution training requirements for individuals involved with the conduct of Clinical Trials. Documentation of this completed training should be maintained as part of the employee records. The minimum mandatory training requirements may include:
See requirements - click here
All study team members listed on protocols and/or performing aspects of the protocol are required to have valid IRB education.
See policy - click here
Applies to all departments and personnel who ship or receive dangerous goods\hazardous materials, diagnostic specimens at Temple University (TU) and Temple University Health System (TUHS), to all work conducted under the authority of TU and TUHS. Non-Temple and contractor personnel must follow the provision of this document while working at these facilities.
Human Subject Protections Training
All study team members listed on protocols and/or performing aspects of the protocol are required to have valid IRB education. Each study team member must have a valid education certificate when listed on any active protocol. To be valid, the education certificate must be within 2 calendar years of the certificate award date and must be from a Temple University approved source.
Initial education must be performed by using the on-line education modules in Human Subjects Protections and Conflicts of Interest and Scientific Misconduct. Re-certification of expired IRB education is required through the IRB and the IRB should be contacted for more information.
The on-line courseware is available at all times and requires prior registration.
There are 3 on-line education programs with the Research Compliance Courseware
Use of Human Subjects in Research - this module provides the ethical basis and regulatory framework for compliance in the protection of human subjects used in research, and is required of all individuals for IRB Certification prior to performing research involving human subjects.
Conflict of Interest and Scientific Misconduct - this module reviews the regulatory framework for identifying and managing conflicts of interest and for handling scientific misconduct, and is required of all key research personnel.
Grants and Contracts - this module gives a general overview of the pre- and post-award process and is recommended for all individuals involved with research grants and contracts.
To register for access to the Web-based training system:
1.
Send e-mail to irb@temple.edu and include the following information. (You must use your Temple University e-mail account, other e-mail accounts will not be recognized by the IRB)
AccessNet ID - check the Cherry and White pages to confirm your ID. If you do not have an AccessNet ID, please follow:
Your Department or School
Type of research (if applicable): Medical Intervention or Social and Behavioral Research
Current title or affiliation with Temple University - indicate if you are faculty, staff, student or identify other affiliation with the University
3.
You will receive a return e-mail (within 1-2 days) indicating that the IRB has activated your AccessNet ID and you may access the system from the Temple IRB web-page.
4.
You may access the on-line training system accessible through the IRB web-site. (click here) (Link is also provided on the IRB Home-Page)
This training is often covered during New Employee Orientation OR Scheduled upon request by individual departments. To schedule a department specific training course orfor more information on safety courses call 2-2520 or contact EHRS through e-mail.
Please Note:
People working with blood or human tissues must receive BOTH initial and annual refresher training for Bloodborne Pathogens. OVPR certifies that trainees will receive the instruction. Training related to blood borne pathogens is provided by the Office of Environmental Health and Safety, which also is responsible for maintaining appropriate training records.
Shipping of Dangerous Goods / Hazardous Materials Training
Joan Moctar, Health Physicist/Industrial Hygiene
Biosafety Officer
Phone: 215-707-0106
Email: joan.devastey@temple.edu
Requirement:
All employees who intend to offer dangerous goods for shipment must first be trained and certified prior to performing any task. Additional training is required upon any change in the regulations.Refresher Training is required Bi-Annually.
