Dell Medical School

Nuts and Bolts Research Series


“Nuts and Bolts” sessions are one-hour forums focusing on various research-related topics.

Materials for review prior to the session can be accessed via the links in the syllabus. Please note that many of the materials to be reviewed prior to the session are a part of the NIH “Introduction to the Principles and Practice of Clinical Research” online course, and if the materials come from this source, it is noted in the syllabus by the words “NIH Course”. The NIH materials are free, but registration is required to access them.

Note: Course enrollment and material access via NIH’s Office of Clinical Research (OCR) Learning Management System (LMS) Portal begins September 1, 2023.

Access the Supplementary NIH Materials

Option 1: Individual Topics
Peruse the individual course lectures on NIH’s YouTube Playlist or NIH’s VideoCast website related to the current Nuts & Bolts topic. This is the best option for participants only wanting to focus on a portion of the IPPCR course material rather than full course.

Option 2: Full Registered Course

    Follow registration instructions at Introduction to the Principles and Practices of Clinical Research (IPPCR). This is the best option for participants wanting the full gamut of the IPPCR course resources available to them all at once.


      Program Syllabus

      A repository of videos from these talks may be found here.

      All sessions are held via zoom, Thursdays 10-11am; available registration links and calendar holds of the series are below.

      #

      Date

      Topic

      Presenter

      Materials to Review Prior to Discussion

      Resources (click for calendar file)

      1

      8/17/23

      Starting Up a Research Study at Dell Medical School

      Kelly Chambers

      (Dell Med accessible only) Office of Research Resources

      Protocol Design Series

      2

      8/24/23

      Developing Protocols and Manuals of Procedures (MOPs)

      Elizabeth Matsui

      NIH Course: Protocols and MOPs

      Protocol Templates for Clinical Trials

      3

      8/31/23

      Deep Dive into Protocols and MOPs

      Susan Whaley

      Defining Standard Protocol Items for Clinical Trials

      Protocol Templates for Clinical Trials

      4

      9/14/23

      Recruitment and Retention

      Maria Cowley-Morillo and Julia Guerra

      Canva to Make Flyers

      5

      9/28/23

      Adverse Events, Unanticipated Problems, and Protocol Deviations

      Michelle Stickler

      UT Human Research

      6

      10/12/23

      Working Parts of Clinical Trials

      Brooke Lasher

      (Dell Med accessible only) Office of Research Resources

      IRB Series

      7

      11/2/23

      All about Institutional Review Board (IRB) Applications, Part 1: Overview

      Anne Burke

      NIH Course: IRB Part 3

      8

      11/9/23

      All About IRB Applications: Part 2: Preparing an IRB Application

      Anne Burke

      UT IRB FAQs

      UT Office of Research Support Human Subjects

      IRB Application Process Guide

      UT IRB forms website

      UT Research Management Suite

      Ascension Seton

      9

      1/11/24

      Ascension Seton Site Approval Process

      Reggie Louis

      IRB vs SAT

      Seton Site Approval Tool (SAT)

      Legal/Ethical

      10

      1/25/24

      Responsible Conduct of Research: Principles and Application

      Charles de Souza

      UT’s Research Integrity and Scholarly Ethics

      11

      2/8/24

      Legal Issues in Clinical Research: Informed Consent and Vulnerable Populations

      Tom Street

      NIH Course: Legal Issues in Clinical Research

      NIH Course: Vulnerable Populations

      12

      2/22/24

      HIPAA and Research

      Tom Street

      NIH HIPAA Privacy Rule

      Intermission

      13

      2/29/24

      Everything You Ever Wanted to Ask a PI but Never Had a Chance To (faculty panel)

      Drs. William Matsui, Alex Haynes, Matt Wilkinson; moderated by Dr. Alison Cahill

      (Dell Med accessible only) Health Transformation Research Institute (links and resources)

      Data Series

      14

      3/7/24

      Engaging the Biomedical Data Science Hub

      Paul Rathouz

      The Care and Feeding of the Biostatistician
      Biomedical Data Science Hub

      15

      3/21/24

      Requesting Electronic Health Record Data for Research

      Patrick Boswell & Stephen Fontenot

      Data Request Intake (for DMS PIs)

      16

      4/4/24

      Data Safety Monitoring Plans and Study Quality Management

      Sierra Houston

      NIH Course: Data and Safety Monitoring Committees

      17

      4/18/24

      Data Collection and Data Quality Management

      Keli Hawthorne

      NIH Course: Data Management and Case Report Forms

      18

      4/25/24

      In the Trenches with the Research Team (Staff Panel)

      tbd

      (Dell Med accessible only) Office of Research Resources