Seminars & Workshops
Obtaining Informed Consent with Special Populations

Are you a clinical research team member obtaining informed consent from human research volunteers?

Could you or your team use information on best practices and strategies for obtaining informed consent from special populations?

Join Tufts CTSI for a blended synchronous/asynchronous workshop focused on providing hands-on practice consenting research participants from special populations. This training has two parts: a required, self-paced pre-work tutorial on Tufts CTSI I LEARN, and a live Zoom practice session.

In the live portion of the workshop, all participants will practice obtaining informed consent with members of Tufts CTSI’s Stakeholder Expert Panel and student actors from the Boston Arts Academy in two role-play scenarios: an adolescent research participant and an adult with temporary diminished capacity. Panel members are former research participants and individuals with experience as simulated patients. This is a learning and skill building opportunity for you, and you will not be evaluated in any way.

Participants must complete all of the pre-work on Tufts CTSI I LEARN in order to receive the Zoom link for the live training. While in the live session your active participation in the role-play activity is required. You will also learn through providing feedback to others and engaging in group discussion. This will ensure that you get the most out of what this training has to offer.

Clinical research coordinators, investigators, research fellows, research nurses, and anyone involved in obtaining informed consent are encouraged to attend.

Learning Objectives

After attending this event, participants should be able to:

  • Demonstrate professional judgement on whether a potential participant has the capacity to provide willing and uncoerced consent.
  • Distinguish between competency and capacity with respect to informed consent conversations.
  • Distinguish between assent and consent to participate in research.
  • Demonstrate (using plain language) explaining the informed consent process, in a virtual setting, to participants from special populations.

Details

Live Session: Thursday, February 3, 2022
3;00-5:00PM
Online via Zoom (a link will be sent to those who register and complete the I LEARN pre-work).

Registration

To attend, please enroll here via Tufts CTSI I LEARN by noon on February 2, 2022.

NOTE: Registration will open on Monday, January 10.

Prerequisite: CITI basic human subjects protection training. Participants will be required to upload proof of CITI completion to the Tufts CTSI I LEARN course site before the live session.

For further information, please contact Noelle Weicker, MHS.

 

 

 

Seminars & Workshops
Obtaining Informed Consent: A Practical Approach

Are you a clinical research team member who obtains informed consent from human research volunteers?

Could you or your team use information on best practices and strategies for obtaining informed consent?

Join Tufts CTSI for a blended synchronous/asynchronous workshop focused on providing hands-on practice consenting research participants. This training will take place in two parts: Part 1 of this workshop will be offered online, self-paced through Tufts CTSI I LEARN; Part 2 will take place in a live Zoom meeting and provide an opportunity to practice obtaining informed consent with members of Tufts CTSI’s Stakeholder Expert Panel. Panel members are former research participants and individuals with experience as simulated patients. This is a learning and skill building opportunity for you and will not be evaluated in any way.

Participants must complete all of the pre-work on Tufts CTSI I LEARN in order to receive the Zoom link for the live training. While in the live workshop, your active participation in the live role-play activity is required. You will also learn through providing feedback to others and engaging in group discussion. This will ensure that you get the most out of what this training has to offer.

Clinical research coordinators, investigators, research fellows, research nurses, and anyone involved in obtaining informed consent are encouraged to attend.

By the end of this workshop, participants of Parts 1 & 2 should be able to:

  • List the essential elements of informed consent.
  • Demonstrate (using plain language) explaining the informed consent process, in a virtual setting.
  • Demonstrate multiple techniques to verify participants’ comprehension.
  • Identify 2-3 key considerations for obtaining informed consent in a remote or virtual setting.

Details

Live session via Zoom: Thursday June 23, 2022, 10:00AM-noon ET 

Registration

To attend, please register here via Tufts CTSI I LEARN.

Prerequisite

CITI basic human subjects protection training. Participants will be required to upload proof of CITI completion to the Tufts CTSI I LEARN course site before the live session.

Seminars & Workshops
Obtaining Informed Consent: A Practical Approach

Are you a clinical research team member, obtaining informed consent from human research volunteers?

Could you or your team use information on best practices and strategies for obtaining informed consent?

Join Tufts CTSI for a blended synchronous/asynchronous workshop focused on providing hands-on practice consenting research participants. This training will take place in two parts.

Part 1 of this workshop will be offered online, self-paced through Tufts CTSI I LEARN.

Part 2 of the workshop will take place in a live Zoom meeting and provide an opportunity to practice obtaining informed consent with members of Tufts CTSI’s Stakeholder Expert Panel. Panel members are former research participants and individuals with experience as simulated patients. This is a learning and skill building opportunity for you and will not be evaluated in any way.

Participants must complete all of the pre-work on Tufts CTSI I LEARN in order to receive the Zoom link for the live training. While in the live workshop your active participation in the live role-play activity is required. You will also learn through providing feedback to others and engaging in group discussion. This will ensure that you get the most out of what this training has to offer.

Clinical research coordinators, investigators, research fellows, research nurses, and anyone involved in obtaining informed consent are encouraged to attend.

Learning Objectives

By the end of this workshop, participants of Parts 1 & 2 will be able to:

  • List the essential elements of informed consent.
  • Demonstrate (using plain language) in explaining the informed consent process, in a virtual setting.
  • Demonstrate multiple techniques to verify participants’ comprehension.
  • Identify 2-3 key considerations for obtaining informed consent in a remote or virtual setting.

Details

Live Session: Thursday, June 23, 2022
10:00AM-noon
Online via Zoom (a link will be sent to those who register and complete the I LEARN pre-work).

Registration

To attend, please enroll here via Tufts CTSI I LEARN by Thursday, June 16, 2022.

Prerequisite: CITI basic human subjects protection training. Participants will be required to upload proof of CITI completion to the Tufts CTSI I LEARN course site before the live session.

Seminars & Workshops
Pfizer Investigator Training Program (iTP) 2021

A foundational International Conference on Harmonization (ICH) Good Clinical Practices (GCP) training on Clinical Trial Management for Junior Level Investigators and Clinical Research Personnel

Tufts CTSI will host the Pfizer Investigator Training Program (ITP)-Facilitating Global Excellence in Clinical Trials.  This unique, two-day, free, live online (via videoconference), workshop is designed for junior-level clinical research personnel (e.g., junior investigators, junior clinical trial coordinators, junior IRB staff) looking to expand their skills related to the clinical trial process.  This eight-hour workshop reviews the entire trial process from planning to close-out. Attendees will gain the fundamental GCP skills required for the planning and conduct of clinical trials and the reporting of resultant data.

Details

Wednesday, September 15 and Thursday, September 16
1:00-5:00PM
via Videoconference

GCP Certificate Requirements

Completion of ITP training satisfies the Pfizer GCP requirement and TransCelerate mutual recognition criteria for conducting clinical trials.

To qualify for the GCP certificate, participants must:

  • Attend all modules in their entirety (8 hours over the course of 2 days)
  • Keep their cameras on for the entirety of the training
  • Not share computers for purposes of confirming individual attendance
  • Participate through discussion, Q&As and responding to polls

Training Modules Include:

  • The Drug Development Process
  • Study Start-up
  • Informed Consent
  • Diversity in Clinical Trials
  • Conducting a Trial
  • Study Oversight
  • Safety in Clinical Trials
  • Pediatric Drug Development
  • Regional Regulations Governing Clinical Trials
  • Pfizer Mentor Program
  • Additional content may be available

Registration

To reserve your seat, please register here via Tufts CTSI I LEARN.