Early-Stage Investigator K12 Training Program (previously KL2)

All scholars are required to complete an Individual Development Plan (IDP). The IDP includes a selfassessment (which includes assessing competencies) and goal setting and is reviewed and signed by the scholar’s primary mentor. Once implemented, the IDP should be reviewed annually with the scholar’s full mentorship team.

K12 scholars are expected to participate in and evaluate all planned trainings and workshops. Details of the schedule will be confirmed closer to the funding start date. Scholars and Co-Directors will meet weekly, via video or in-person (where practical), to discuss and solve current problems that scholars are experiencing with either their career development or research activities. These sessions will continue yearround, including summer, and are considered mandatory. Planned absences must be submitted in writing and approved by K12 co-directors. Session evaluations are mandatory within one week of the session.

Scholars are also expected to comply with all program and grant reporting requirements through provision of progress reports. K12 scholars are required to complete a formal, written progress report annually during the program. Scholars are required to meet the program coordinator quarterly to provide updated progress information (grant submissions, publications, awards, etc).

The K12 program must provide annual reporting to the NIH regarding scholars’ outcomes for 15 years. Thus, scholars must agree to submit upon request a progress report and updated CV annually for up to 15 years after graduating from the program.

Scholars conducting research that meets the NIH definition of a clinical trial are responsible for complying with all applicable ClinicalTrials.gov registration and results reporting requirements. Scholars must maintain compliance with all institutional, NIH, and federal requirements for timely registration, record maintenance, and results reporting throughout the duration of their award. Failure to maintain ClinicalTrials.gov compliance may affect continued eligibility for K12 support and future NIH funding.

Other Required Documents if Selected for the K12 Award

Candidates who are selected for the K12 Award will be required to submit supplemental documents required by NCATS prior to the start date of the K12 Award. These include:

• RB or IACUC protocol for the proposed research project (approval can be pending)

• Informed Consent document, if applicable

• Human Subjects section, if applicable

• Clinical Trial information, as indicated (Investigator’s Brochure, package insert, IND or IDE documentation, IND exemption, or IDE waiver)

• Inclusion Plan for Women, Minorities, and Children, if applicable

• Targeted Enrollment Table or Inclusion Data Record, if applicable

• Data and Safety Monitoring Plan (DSMP) and Board (DSMB), if applicable

• Date of most recent CITI certification

All mentors (primary and secondary) are required to attend a 4-hour mentor training that includes an overview of the K12 program, expectations, logistics, and mentoring best practices.

Primary mentors must complete a mentoring self-assessment annually.

After being notified of funding, K12 scholars and the primary mentors must sign a memorandum of understanding (a template is provided by the K12 program) that serves as an agreement on the part of the mentor and mentee to follow best practices for mentoring relationships.

All mentors (primary and secondary) are expected to participate in bi-annual meetings with K12 leadership, to review scholar progress.

At the end of the scholar’s program, there is a graduation ceremony that all mentors (primary and secondary) are expected to attend.

In addition, primary mentors must:

• Review IDPs with scholars on an ongoing basis and provide a formal evaluation to be submitted to the K12 program on an annual basis.

• Complete a mentoring self-assessment annually.

• Sign a memorandum of understanding (a template is provided by the K12 program) that serves as an agreement on the part of the mentor and mentee to follow best practices for mentoring relationships (upon funding).

Each year, Penn State Clinical and Translational Science Institute’s external advisory board meets with the leadership, members and K12 and other scholars within the institute. Scholar attendance is required at this meeting, typically in Hershey. Select scholars may be asked to give a brief presentation on their research and scholarly activity.

In addition, there may be additional mandatory CTSI programmatic activities each year.

K12 scholars may select from graduate courses offered at the University, including clinical and translational science and public health sciences. Educational funds can be included in the applicant’s K12 direct cost budget.

Scholars may enroll in one or more courses, as needed, with or without earning a certificate or degree. Most courses are offered in designated time slots two to three evenings per week or a designated early morning session in order to facilitate attendance by both clinicians and non-clinicians, including individuals based at University Park. Several courses are available via video conference between Hershey and University Park.

Provost Endorsement Program

The K12 program provides a supportive environment for junior faculty scholars to acquire the skills and experience needed to become successful, independent clinical and translational scientists. This is accomplished through coursework, mentored research, workshops, and career development programs. There are 8 scholars per year selected from a competitive pool of applicants submitted by junior faculty across the University. You must be a current K12 Scholar to be eligible to participate in this .