MGH Division of Clinical Research

Good Clinical Practice in Research at an Academic Research Institution

Ended: June 24, 2021

Good Clinical Practice in Research at an Academic Research Institution
May 27 | June 3 | June 10 | June 17 | June 24
Zoom
Sponsored by the MGH Division of Clinical Research, Partners Human Research Committee and Partners Human Research Quality Improvement Program
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting human subjects’ research. GCP guidelines define the roles and responsibilities of the IRB, investigator, and sponsor as well as describe the essential documents needed for the conduct of a study. Compliance with GCP assures that the rights, safety, and welfare of subjects are protected and that the data produced from the research are credible.

After completing this training, the learner will have a comprehensive understanding of GCP and be able to apply those practices to the conduct of clinical research.

Session 1: May 27th 2:00-4:15pm
• Why is GCP important?
• Introduction to Good Clinical Practice
• Privacy and Security in Clinical Research

Session 2: June 3rd 2:00-4:30pm
• Research Protocol
• Regulatory Requirements for Human Subjects Research
• Study Monitoring
• Special Considerations for Pediatric Studies

Session 3: June 10th 2:00-4:30pm
• Regulatory Binder, Essential Documents and Redcap
• Process of Informed Consent
• FDA Regulations: IND/IDE

Session 4: June 17th 2:00-4:30pm
• Reportable Events in Human Research
• Drug Accountability: Investigational Drug Pharmacy
• Drug & Device Accountability: Site Perspective
• SOPs to Comply with GCP

Session 5: June 24th 2:00-4:00pm
• Special Topics in Human Research
• Study Audits
• Research Misconduct Prevention
• Wrap Up

Note: To receive a certificate of completion a participant must attend all 5 sessions and successfully pass a post-course assessment through RedCap. RCR Eligibility: Completion of all five sessions of this course will fulfill two lecture/discussion requirements.

Registration is required. Please contact Amy Quinkert with questions.


Programs:
NIH-Funded Investigators and Clinical Trial Site Staff Responsible Conduct of Research Program at MGH Clinical Investigator Program Experienced Clinical Research Coordinator Beginner Clinical Research Coordinator Clinical Research Investigator

Categories:
Clinical Research Ethical Oversight

Sponsor:
MGH Division of Clinical Research

Sessions

May 27, 2021 05/27/21
2PM-4:15PM
2 PM – 4:15 PM
STRATUS Online Moodle, None
June 3, 2021 06/3/21
2PM-4:30PM
2 PM – 4:30 PM
STRATUS Online Moodle, None
June 10, 2021 06/10/21
2PM-4:30PM
2 PM – 4:30 PM
STRATUS Online Moodle, None
June 17, 2021 06/17/21
2PM-4:30PM
2 PM – 4:30 PM
STRATUS Online Moodle, None
June 24, 2021 06/24/21
2PM-4:30PM
2 PM – 4:30 PM
STRATUS Online Moodle, None

Reviews

Yahya A:
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Date Attended: June 24, 2021, 3:59 p.m.
Date Reviewed: June 24, 2021, 5:44 p.m.
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Date Reviewed: June 24, 2021, 4:42 p.m.
Anonymous: This course was filled with lots of good information. It would be helpful in the future to provide small breaks between the speakers and make the sessions more interactive. Also, maybe include more practical/real world examples.
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Date Reviewed: June 24, 2021, 4:36 p.m.
William B:
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Date Attended: June 24, 2021, 4 p.m.
Date Reviewed: June 24, 2021, 4:01 p.m.
Anonymous: Sessions were too long and not interactive enough so it was extremely hard to pay attention.
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Date Reviewed: Jan. 12, 2021, 10:55 p.m.
Sailaja M: I really found the course very useful. All instructors are experts in their relevant areas and gave very practical insights into the execution of GCP guidelines and how each of these actually matter. The case studies were also very useful.
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Date Attended: Dec. 31, 2020, 8:37 a.m.
Date Reviewed: Dec. 31, 2020, 11:39 a.m.
Ema P: I really liked the topics and updates that are provided in all presentations. Keep up with with excellent work!
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Date Attended: Dec. 17, 2020, 10:46 a.m.
Date Reviewed: Dec. 17, 2020, 1:03 p.m.
Anonymous: It is harder to focus on the content in a zoom meeting since it is less interactive than in person classes. It is easy to be distracted and try to multi-task during these long zoom sessions. I also did not receive the slides for the last session and the test that needs to be completed. There were several other in the department who also had the same issue.
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Date Reviewed: Dec. 17, 2020, 12:21 p.m.
Anonymous: Overall a very well-done course. Case studies, and examples are the most helpful way to make the content relevant and less of an academic exercise. Having the slides for the lecture is helpful to be able to jot things down on the right page in real time.
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Date Reviewed: Dec. 17, 2020, 11:35 a.m.
Carmen G:
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Date Attended: Dec. 17, 2020, 10:43 a.m.
Date Reviewed: Dec. 17, 2020, 11:34 a.m.
Sara S:
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Date Attended: Dec. 17, 2020, 10:52 a.m.
Date Reviewed: Dec. 17, 2020, 11:02 a.m.
Anonymous: A very informative course. Would suggest more opportunity for engagement during the lectures.
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Date Reviewed: Dec. 17, 2020, 10:53 a.m.
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Date Reviewed: Sept. 3, 2020, 8:26 p.m.
Abdurahman K:
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Date Attended: June 24, 2021, 4:05 p.m.
Date Reviewed: July 23, 2020, 11:05 a.m.
Hannah G:
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Date Reviewed: July 14, 2020, 3:47 p.m.
Anonymous: The teaching faculty were knowledgeable on the presented topics and were able to provide comprehensive insight. However, it was hard to picture how to apply such knowledge. I missed having practical examples and/or quizzes during the lectures to better understand how to make practical use of the material. I also felt that the length of the lectures could be shorter.
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Date Reviewed: July 9, 2020, 11:58 p.m.
Yvonne C:
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Date Attended: July 6, 2020, 11:24 a.m.
Date Reviewed: July 6, 2020, 11:30 a.m.
Anonymous: Wonderful and knowledgeable teachers, well organized, good content. I think that it would benefit from more interactive teaching and some break out sessions/options for more engaged adult learning rather than large chunks of lecture.
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Date Reviewed: July 4, 2020, 7:18 a.m.
Anonymous: Having a brief quiz after each session would be beneficial for reviewing the content. Very practical 'how-to do it right' course.
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Date Reviewed: July 3, 2020, 4:28 a.m.
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Date Reviewed: July 2, 2020, 3:33 p.m.
Nivedita C:
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Date Attended: Dec. 17, 2020, 10:52 a.m.
Date Reviewed: July 2, 2020, 3:03 p.m.
Anonymous: I think it would be beneficial to have comprehensive tests after each session. I also would like to see it more be more interactive by incorporating questions. I would also recommend make the sessions shorter - it was hard to pay attention for 2.5 hours.
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Date Reviewed: July 2, 2020, 2:58 p.m.
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Date Reviewed: July 2, 2020, 2:41 p.m.
Kutlu K:
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Date Attended: July 2, 2020, 2:11 p.m.
Date Reviewed: July 2, 2020, 2:29 p.m.
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Date Reviewed: July 2, 2020, 2:22 p.m.
Anonymous: This course is very helpful, even for people like myself who have been in this field for a while. I think slightly more Q&A time would've been valuable, especially for "mixed bag" issues. Getting face-to-face time (or virtual face time) with the "high ups" within regulatory compliance is very valuable - maybe advertise for people to think of questions beforehand and dedicate specific time to answering them?
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Date Reviewed: July 2, 2020, 2:17 p.m.
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Date Reviewed: July 2, 2020, 2:16 p.m.
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Date Reviewed: July 2, 2020, 2:15 p.m.
Anonymous: Good course on clinical practice. Some content is a bit repetitive, so everything could be compressed in much lesser time.
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Date Reviewed: July 2, 2020, 2:10 p.m.
Kirsten D:
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Date Attended: Dec. 12, 2019, 2:16 p.m.
Date Reviewed: March 6, 2020, 11:36 a.m.
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Date Reviewed: Feb. 14, 2020, 1:07 p.m.
Anonymous: The "Potpourri of IRB Issues" is the best
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Date Reviewed: Jan. 22, 2020, 12:42 p.m.
Fugui Z: This is a great course. The lectures are wonderful and the slides are well prepared. Thanks very much.
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Date Attended: Dec. 12, 2019, 2:27 p.m.
Date Reviewed: Jan. 22, 2020, 10:05 a.m.
Anonymous: Maybe not so long on each session. towards the end of each session I would lose focus no matter how important or interesting the topic. 2.5+ hours is a long time to sit and listen to people speak.
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Date Reviewed: Jan. 21, 2020, 1:28 p.m.
Emily L:
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Date Attended: Dec. 12, 2019, 2:08 p.m.
Date Reviewed: Jan. 13, 2020, 11:41 a.m.
Liang Z: It is very approciate for us having the opportunity for this GCP class.
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Date Attended: Dec. 12, 2019, 2:31 p.m.
Date Reviewed: Jan. 10, 2020, 4:03 p.m.
Anonymous: Only suggestion I would make is for the instructors to be aware of things we've gone over in previous lectures to decrease the amount of repetition. Overall very informative.
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Date Reviewed: Dec. 16, 2019, 4:51 p.m.
Michael S:
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Date Attended: Dec. 12, 2019, 2:30 p.m.
Date Reviewed: Dec. 16, 2019, 3:44 p.m.
Anonymous: I think it would be helpful next time if there was a Q&A option that can be typed and if it can't be answered during the session then it can be sent in an email or attached as a follow up email.
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Date Reviewed: Dec. 16, 2019, 2:51 p.m.
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Date Reviewed: Dec. 16, 2019, 2:40 p.m.
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Date Reviewed: Dec. 16, 2019, 2:35 p.m.
Jianhai G:
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Date Attended: Dec. 12, 2019, 2:26 p.m.
Date Reviewed: Dec. 16, 2019, 2:13 p.m.
Anonymous:
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Date Reviewed: Dec. 16, 2019, 2 p.m.
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Date Reviewed: Dec. 16, 2019, 1:48 p.m.
Judith C: very informative & helpful
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Date Attended: Dec. 12, 2019, 2:28 p.m.
Date Reviewed: Dec. 16, 2019, 1:47 p.m.
Anonymous:
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Date Reviewed: June 28, 2019, 8:08 a.m.
Jianhai G:
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Date Attended: Dec. 12, 2019, 2:26 p.m.
Date Reviewed: June 28, 2019, 7:57 a.m.
Scott M: Great course that allowed me to understand many of the nuances of our research that have importance in documentation and proper delegation/sharing of work-load.
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Date Attended: June 27, 2019, 1:58 p.m.
Date Reviewed: June 28, 2019, 6:19 a.m.
Surendra C: Great course.Very comprehensive and content were practical in day to day clinical research practice.
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Date Attended: June 27, 2019, 2:03 p.m.
Date Reviewed: June 28, 2019, 1:06 a.m.
Anonymous:
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Date Reviewed: June 27, 2019, 7:17 p.m.
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Date Reviewed: June 27, 2019, 2:07 p.m.
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Date Reviewed: May 31, 2019, 1:39 p.m.