NIH NCI DCP AQuIP Website

Training and Resources


The AQuIP Training and Resources page contains recorded webinars from the C2012 Web Seminar Series as well as a variety of helpful recruitment resources to help you successfully meet enrollment targets while conserving staff resources. Consortia recommendations for additional webinars and resources are welcome via email to the DCP Helpdesk.

Webinars
Webinars

Harnessing the Immune System to Prevent Cancer: Basic Immunologic Mechanisms & Their Application to Clinical Trials of Vaccines Part 2: The Vaccines

Barbara K. Dunn, Ph.D., M.D, Medical Officer in the Biometry Research Group (BRG) in the National Cancer Institute (NCI)'s Division of Cancer Prevention (DCP), provides an overview of the general principles and key components of vaccines focusing on examples from the DCP 2012 Consortium Vaccine Trials, vaccines to prevent cancers caused by infectious agents and non-infection associated cancers, and COVID-19 vaccine development updates

Air Date: 8/3/2020
Presentation Slides (PDF, 3624KB)
Webinar Video (MP4, 83MB)

Harnessing the Immune System to Prevent Cancer: Basic Immunologic Mechanisms & Their Application to Clinical Trials of Vaccines Part 1: The Basics

Barbara K. Dunn, Ph.D., M.D, Medical Officer in the Biometry Research Group (BRG) in the National Cancer Institute (NCI)'s Division of Cancer Prevention (DCP), provides an overview of the physical components of the immune system, what is carcinogenesis, innate versus adaptive immunity, and key components of vaccines and their use in preventing cancer caused by infectious agents and preventing non-infection associated cancer.

Air Date: 7/13/2020
Presentation Slides (PDF, 1820KB)
Webinar Video (MP4, 73MB)

AQuIP Demonstration for the Denosumab Ovary Study

Timothy Kesslar, Clinical Operations Specialist for the DCP Monitoring/Auditing and Informatics Contract, presents a live demonstration of the AQuIP OARS pre-screen function for DCP protocol MDA2017-09-03. The demonstration includes pre-screen criteria for the Denosumab/Overy study and step by step review of the four outcomes within the AQuIP OARS pre-screen data system.

Air Date: 6/24/2020
Webinar Video (MP4, 141MB)

Making Informed Consent More Meaningful in the Era of the Revised Common Rule

Dr. Yvonne Lau, Director of the Division of Education and Development at the Department of Health and Human Services Office for Human Research Protections, provides an overview of the purpose and requirements of informed consent, how to present the information to participants, strategies for organizing and facilitating understanding, and the importance of providing context in clinical trials. Dr. Lau also provides resources for participating in research and making informed decisions, as well as lectures and quick references for sites.

Air Date: 6/15/2020
Webinar Video (MP4, 50.3MB)
Presentation Slides (PDF, 2258KB)

Responsibilities of the Research Team

Elizabeth Ness, Director of the Office of Education and Compliance at the Center for Cancer Research, provides an overview of the roles of the research team focusing on the roles of the investigator, sub-investigators, study coordinator, Clinical Data Manager, and the participants. Ms. Ness reviews general responsibilities of the clinical research team, what makes a research team successful, delegation and supervision, an overview of professional organizations, as well as helpful resources.

Air Date: 5/26/2020
Webinar Video (MP4, 14.2MB)
Presentation Slides (PPT, 430KB)

Registration and Credential Repository

Matthew Boron, a Senior Clinical Research Pharmacist at the National Cancer Institute Cancer Therapy Evaluation Program, presents an overview of the National Cancer Institute's Registration and Credential Repository. Mr. Boron describes why the Registration and Credential Repository (RCR) was implemented, as well as explains RCR requirements and how to access the system. The presentation focuses on key points such as RCR capabilities, registration types, documentation requirements, and more. Mr. Boron demonstrates how to access and navigate the Registration and Credential Repository system, as well as provides helpful tips including checklists and guides for registration.

Air Date: 2/25/2020
Webinar Video (MP4, 102MB)
Presentation Slide (PDF, 1.51MB)

AQuIP OARS Refresher Training

Tiana Tower, the DCP Help Desk Specialist, reviews the AQuIP OARs monthly deliverable process, account creation, and maintenance in this 15-minute AQuIP OARS Refresher Training. She also discusses the updates to the monthly AQuIP Zone Monitoring Report (ZMR) deliverable and the new optional Pre-screen feature. Finally, to reduce AQuIP OARS users' workload and the number of monthly queries, Ms. Tower identifies the three most common data entry issues, how to avoid these, and a few shortcuts and tips to streamline users' entries into AQuIP OARS.

Air Date: 10/22/2019
Webinar Video (MP4, 12.5MB)
Presentation Slide (PDF, 1.31MB)

Creating a Culture of Research

Eileen Dimond, a Nurse Consultant and Program Director for the Division of Cancer Prevention, presents lessons learned and factors that influence research culture based on the NCI program experience. Ms. Dimond also discusses strategies to assess, build, and support research infrastructure.

Air Date: 7/23/2019
Webinar Video (MP4, 42.6MB)
Presentation Slide (PDF, 2.34MB)

CIRB Mandatory Reporting

Lisa Rooney, a Human Research Protections Program Consultant for the Division of Cancer Prevention, and Amanda Sly, the CIRB Director of Central Operations at the National Cancer Institute, present an overview on reporting obligations. This presentation focuses on how to use the CIRB's algorithm to determine whether unanticipated problems, serious or continuing noncompliance, and protocol deviations are reportable and the steps to properly submit each.

Air Date: 6/27/2019
Webinar Video (MP4, 28.043MB)
Presentation Slide (PDF, 362KB)

Equitable Selection of Subjects

Lisa Rooney, a Human Research Protections Program Consultant for the Division of Cancer Prevention, highlights equitable selection of subject considerations, specifically for Limited English Proficiency Subjects (LEPS), and applying these considerations to a case study to better understand LEPS exclusions.

Air Date: 03/26/2019
Presentation Slides (PDF, 0.13MB)
Article 1 (PDF, 0.3MB)
Article 2 (PDF, 0.06MB)

Regulatory Documentation and Submissions for C2012 Clinical Trials

Maria Bagoly, MA, Manager, Clinical Operations provides Consortia 2012 regulatory documentation and submission process guidance as well as an overview of updates in progress for the DCP SOP 1: Regulatory Documents.

Air Date: 06/27/2018
Webinar Video (MP4, 72.25MB)
Presentation Slides (PDF, 1.59MB)

Increasing Awareness of the Local CIRB Review/Process/Challenges for CIRB approved Consortia Studies and Amendments

Laura Covington, NCI CIRB Director of Local Operations explains the CIRB review process and provides clarification and instruction for common CIRB challenges faced by Consortia Studies.

Air Date: 05/30/2018
Webinar Video (MP4, 97.1MB)
Presentation Slides (PDF, 90.3 KB)

Assessing Clinical Trial Workload

Marge Good, Nurse Consultant with the National Cancer Institute's Division of Cancer Prevention, presents the importance of clinical trial workload assessment and demonstrates how the ASCO Clinical Trial Workload Assessment Tool effectively determines workload metrics and benchmarks to assist research site management.

Air Date: 01/09/2018
Webinar Video (MP4, 72.71MB)
Presentation Slides (PDF, 1.0MB)

Vaccines for Infectious Agents and Cancer Prevention and Control

Dr. Sahasrabuddhe, Program Director with the Breast and Gynecologic Cancer Research Group, provides an overview of vaccination principles, the burden of infection-associated cancers, vaccines against infectious agents causing cancer, and issues in increasing implementation of vaccination on a global scale.

Air Date: 12/07/2017
Webinar Video (MP4, 69.33MB)
Presentation Slides (PDF, 342KB)

Immuno-Prevention of Cancers Not Associated with Infectious Agents

Dr. Margaret Wojtowicz, Medical Oncologist with the DCP-Lung and Upper Aerodigestive Cancers Research Group, provides a presentation of targets, antigens and strategies used for the prevention of tumors not associated with infectious agents and an overview of vaccines currently being investigated in studies conducted at DCP.

Air Date: 11/16/2017
Webinar Video (MP4, 72MB)
Presentation Slides (PDF, 2.287MB)

Harnessing the Immune System to Prevent Cancer: Basic Immunologic Mechanisms (the language of immunology)

Dr. Barbara Dunn, Medical Monitor with the Chemopreventive Agent Development Research Group of the Division of Cancer Prevention, provides an overview of how immunologic mechanisms are used in medical interventions to treat and prevent cancer including antibodies as drugs, vaccine principles, and immune checkpoint inhibitors.

Air Date: 10/23/2017
Webinar Video (MP4, 31MB)
Presentation Slides (PDF, 2.41MB)

CTCAE and Source Documentation

Elizabeth Ness, RN, MS, Director, Office of Education and Compliance Center for Cancer Research, provides a comprehensive training of Adverse Event data collection, MedDRA and CTCAE terminology, assessment and documentation for the DCP Consortia 2012.

Air Date: 9/26/2017
Webinar Video (MP4, 14.2MB)
Presentation Slides (PDF, 430KB)

CIRB

Laura Covington, NCI CIRB Director of Local Operations demonstrates CIRB website navigation as well as provides a review of the CIRB submission and review process.

Air Date: 7/26/2017
Webinar Video (MP4, 66.363MB)
Presentation Slides (PDF, 61KB)

AQuIP Update 2017

Ellen Richmond, Nurse Consultant with the Gastrointestinal and Other Cancers Research Group of Division of Cancer Prevention highlights the AQuIP program purpose objectives, goals and its impact on Consortia 2012 accrual improvement and introduces how AQuIP data and study design factors can help with study accrual feasibility.

Air Date: 6/29/2017
Webinar Video (MP4, 42.037MB)
Presentation Slides (PDF, 1415KB)

Good Clinical Practice (GCP)

Bridget Foltz, Policy Analyst with the Office of the Commissioner (OC) Office of Good Clinical Practice (OGCP) U.S. Food and Drug Administration defines the goals of good clinical practice (GCP), key GCP principals, staff responsibility, and informed consent. She also provides a variety of resources for information on electronic records and source data, along with other GCP training opportunities.

Air Date: 4/19/2017
Webinar Video (MP4, 12.43MB)
Presentation Slides (PDF, 155KB)

SAE Reporting

Dr. Gary Della' Zanna, Medical Officer at the Division of Cancer Prevention, provides an overview of the DCP Consortia 2012 SAE Reporting process, applicable terminology and the FDA’s IND Safety Final Rule.

Air Date: 1/19/2017
Webinar Video (MP4, 38MB)
Presentation Slides (PDF, 231KB)

Protocol Deviations

Vanessa Laroche, Quality Assurance Specialist for the DCP Monitoring/Auditing and Informatics Contract, defines protocol deviations, discusses their impact, reviews Investigators responsibilities, and explains the new DCP reporting requirements. She shares tips on avoiding frequent deviation reporting mistakes, reviews 2016 deviation trends and recommends associated actions to help prevent protocol deviations.

Air Date: 12/08/2016
Webinar Video (MP4, 28MB)
Presentation Slides (PDF, 614KB)

The ABCs of Chemoprevention

Dr. Barbara Dunn, Medical Monitor with the Chemopreventive Agent Development Research Group of the Division of Cancer Prevention, provides a fundamental overview of cancer, carcinogenesis, cancer chemoprevention, and the Consortia chemoprevention clinical trial design.

Air Date: 10/27/2016
Webinar Video (MP4, 18.5MB)
Presentation Slides (PDF, 5.35MB)

Unraveling the DCP Consortia

Maggie House, Nurse Consultant with the Prostate and Urologic Cancer Research Group of the Division of Cancer Prevention, highlights the Consortia mission, framework, member responsibilities, and protocol development process.

Air Date: 09/27/2016
Webinar Video (MP4, 8.15MB)
Presentation Slides (PDF, 11.8 MB)
Resources
Resources

This guide provides AQuIP OARS navigation and data entry instructions for CLOs and POs.


This guide provides AQuIP OARS navigation and data entry instructions including pre-screen data collection instructions for CLOs and POs.


Consortia 2012 OARS Training

Liz Walsh, Clinical Operations Specialist for the DCP Monitoring/Auditing and Informatics Contract, demonstrates AQuIP OARS navigation and data entry for CLOs and POs in this 25 minute webinar recording. If you are familiar with the AQuIP OARS program and would like to skip to the demonstration, you can go to the 4:30 mark.

Air Date: 11/16/2018
Webinar Video (MP4, 9MB)

A Center for Cancer Research National Cancer Institute Presentation outlining appropriate clinical research practice documentation.


Link to the Office for Human Research Protections resource to review Informed Consent facts and understanding.


Resource for potential research participants describing the Informed Consent process and details the history and regulation of clinical trials.


Elizabeth Ness, RN, MS, & Maureen Edgerly, RN, MA from NCI present 15-minute training recording providing an overview of key roles of the research team aired April 2016.


Brief article explaining the basics of good documentation practices following the key ALCOA principles: Documentation that is Attributable, Legible, Contemporaneous, Original & Accurate.


A 2016 Presentation providing recruitment strategies for minority and specific generational demographics.


You’ve Got the Power booklet to Increase Minority Participation and Awareness of Clinical Trials.


Increase Minority Participation and Awareness of Clinical Trials (IMPACT) Video.


National Medical Association fact sheet on the importance of minority participation in clinical trials.


Official Twitter account of the NCI Division of Cancer Prevention.