Training & Compliance
Investigators and Study Team members must complete web-based tutorials through the CITI Program provided by UT Austin. Conflict of Interest and Human Subjects training through CITI are required for all members of the research team. Good Clinical Practice (GCP) Training is strongly recommended. Additional targeted resources are available to meet the training needs of each Study Team member, depending on their roles and responsibilities on the study.
CITI accounts that were initiated through Ascension Seton (Ascension) or other organizations must be affiliated with UT Austin CITI. Once you affiliate and bring over your existing modules, your training will be incomplete due to the additional requirement for one elective, which must be completed by your next training due date.
This transition from Ascension CITI to UT Austin CITI training will take place over the next three years with the expectation that all researchers will come into alignment by June 30, 2018.
Required Training and Certification For Researchers
Principal Investigators and all members of the Research Team must complete training through CITI, using their UT Direct single sign on as follows:
1. Affiliate your Ascension or other existing CITI account with UT Austin:
Once you affiliate and bring over your existing modules, your CITI training will be incomplete due to the additional requirement for one elective. Remember to complete one elective by your next due date.
2. Complete Good Clinical Practice (GCP) Training:
GCP Training is required for all members of their Research Team who are involved in the conduct, oversight, or management of NIH-funded clinical trials. Ascension Seton and Dell Medical strongly recommend GCP Training for ALL those engaged in human subject research.
3. Complete CITI Training for Human Subject Research by your NEXT due date:
The Required Modules/Trainings for Biomedical Research are:
- Belmont Report and CITI Course Introduction (ID: 1127)
- Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2)
- Informed Consent (ID: 3)
- Social and Behavioral Research (SBR) for Biomedical Researchers (ID: 4)
One of the following must also be completed as an elective:
- Genetic Research in Human Populations (ID: 6)
- FDA-Regulated Research (ID: 12)
- Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680)
4. Complete Conflict of Interest and Financial Interest Disclosure:
Principal Investigators and members of the Research Team who are engaged in human subject research must have acknowledged that they have read the Promoting Objectivity in Research by Managing, Reducing or Eliminating Financial Conflicts of Interest Policy and have completed a Financial Information Disclosure (FID) form. The FID MUST include ALL research projects in which you are engaged, regardless of location as well as financial disclosures related to your job responsibilities at Ascension Seton or UT Austin.
Dangerous Goods Training
International Air Transport Association (IATA) training is required for any Ascension Seton Associate who prepares, transports, or causes dangerous goods to be transported by a public carrier. Associates must follow specific regulations and must have proof of training. Upon completion of this course, you will be eligible to take an online self-assessment quiz to obtain a Dangerous Goods Shipping training-completion certificate. This self-paced training and evaluation process is offered by Mayo Medical Laboratories.
Sponsored Projects Finance Training
Ascension Seton offers quick reference guides for working with ClinCard, the software used for research participant stipends. Training includes instruction on how to request, load and replace cards.
COMPASS, which stands for Care, Opportunity, Mission, Promise, Access, Safety and Standardization is Seton’s electronic medical records system. COMPASS training is essential for conducting, coordinating, and obtaining data for research.
Pharmacy Staff Research Training & Orientation
The Investigational Drug Research support team provides study-specific training for pharmacy staff involved in research protocols. This includes chemotherapy and intravenous preparations of study drug. More information is available from the Ascension Seton Investigational Drug Pharmacy Services (IDPS) Team.