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Clinical Research Boot Camp 2022

Videos and Resources

Videos and Resources

Click the boxes below to find videos, handouts and related resources for each session of Clinical Research Boot Camp 2022!

How to Get Started as an Investigator in an Externally Sponsored Study

SESSION VIDEO

Session Description: Panel members described their initial experience as investigators in clinical trials, including how well their prior training prepared them for the new role, whether they encountered any surprises, and how they managed unfamiliar responsibilities.

Panelists: Stephanie Lee (Moderator), Cate Pihoker, Radica Alicic, and John A. Thompson

Resources:

How to Make Best Use of Monitors and Coordinators

SESSION VIDEO

Session Description: Panel members representing investigators and staff discussed best practices in meeting regulatory requirements through training, early identification of problems and implementation of corrective action plans.

Panelists: Nora Disis (Moderator), Guang-Shing Cheng, Andrew L. Coveler, Sharon McNamara, and Marcie Hall

Resources:

How to Make the Transition from Investigator to Local PI for an Externally Sponsored Study

SESSION VIDEO

Session Description: Panel members discussed how they identified and developed a specific area of expertise that offered a career opportunity as a clinical investigator. They also discussed how they prepared themselves to assume responsibilities as a PI and learned how to manage a study team.

Panelists: Bonnie Ramsey (Moderator), Kelley Branch, Filippo Milano, and Mignon Lee-Cheun Loh

Session Materials:

2 MBSLIDE PRESENTATION: How to Make the Transition from Investigator to Local PI for an Externally Sponsored Study

Resources: 

How to Launch and Conduct an Investigator-Initiated Trial with or without Pharma Support

SESSION VIDEO

Session Description: Panel members discussed how they have designed clinical trials and obtained the necessary financial support to complete the study successfully. Supply of the investigational product for these studies is a key consideration, often requiring support from a pharmaceutical manufacturer.

Panelists: Stephanie Lee (Moderator), Ryan Cassaday, Sarah Leary, Peter Leary, and John B. Liao

Resources:

How to Navigate an IND Application and Trial Under FDA Oversight

SESSION VIDEO

Session Description: Panel members explained when and why FDA oversight through an IND is necessary. They highlighted FDA guidance documents that explain the expectations that come with an IND and how they apply in an academic setting.

Panelists: David Hammond (Moderator), Lynn M. Rose, Ajay Gopal, and Danielle Zerr

Resources:

How to Navigate the Start-Up Process: Tips for Efficiency from Professionals

SESSION VIDEO

Session Description: The clinical trial start-up process is notoriously complex at any institution. Panel members discussed how they have found ways to anticipate problems and improve efficiency, especially in situations where they do not have full control.

Panelists: John K. Amory (Moderator), Lara B. Schiff, Ashley McCauley, and Jiwon Yeo

Resources:

If We Build It, Will They Come? Strategies for Recruitment

SESSION VIDEO

Session Description: Panel members discussed how they estimate the numbers of subjects who fulfill both the inclusion and exclusion criteria for a study. An equally important consideration is the proportion of eligible subjects who would be willing to participate in the study based on the anticipated benefits balanced by burdens of participation.

Panelists: Paul J. Martin (Moderator), Amal Saleh, Michael Donahue, and Michael Louella

Session Materials:

166 KBHANDOUT: Recruitment Tips155 KBHANDOUT: Recruitment Strategizing Worksheet

Resources:

Can We Afford to Do This Study? How to Prepare and Evaluate a Budget

Session Description: Panel members discussed how they estimate costs of coordinator effort, data collection and reporting, and financial management. They offered tips on how to account for costs associated with protocol revisions, monitoring visits and unexpected sponsor or CRO requirements. They also explained how they negotiate the contract with the sponsor or CRO so as to avoid a deficit.

Panelists: Paul J. Martin (Moderator), Jiwon Yeo, Heather Rasmussen, Tanya Chiatovich, and Stephanie Lewis

Resources:

Roles, Responsibilities and Relationships: How Do We Work in Teams?

SESSION VIDEO

Session Description: Panel members discussed the allocation of responsibilities across team members according to their training. They explained how they communicate expectations and accountability and how they devise contingency plans for changes in staffing.

Panelists: Paul J. Martin (Moderator), Alana Clark, Fatima Ranjbaran, and Roxanne Moore

Resources:

Can We Really Do This Study? How to Read a Clinical Trial Protocol

SESSION VIDEO

Session Description: Panel members will discuss how they determine whether a protocol is a good fit for the team and how easily the work could be accommodated within existing clinical practices and capabilities at our center.

Panelists: Paul J. Martin (Moderator), Lori Jarrett, Elizabeth Stohr, and Kari Stricker

Resources: