MGH Division of Clinical Research

Human Subjects Research Recordkeeping and Record Retention

Ended: May 12, 2021

Speaker: Pamela Richtmyer, Director, Mass General Brigham Human Research Quality Improvement Program
Description:
Investigators are required to maintain records of their human research activities. Good recordkeeping is essential for verifying the integrity of study data produced and for demonstrating investigator compliance with applicable regulations, and institutional policies and procedures. This presentation will cover: recordkeeping requirements for regulatory and subject files, maintenance and storage options, common errors identified in inspections and audits, as well as retention requirements for study files.

Other Offerings, Save the Date- Registration to Come: Monday, April 26th 10:00-11:30am, Wednesday, July 21st 1:00-2:30pm, Wednesday, October 20th 1:00-2:30pm

Please contact Tiereny Morrison-Rohlfs at tmorrison-rohlfs@partners.org with questions.



Category:
Research Quality Improvement

Sponsor:
MGH Division of Clinical Research

Sessions

May 12, 2021 05/12/21
1PM-2:30PM 		1 PM – 2:30 PM
STRATUS Online Moodle, None

Other Offerings

Past Offerings
Human Subjects Research Recordkeeping and Record Retention June 9, 2021 06/9/21
Human Subjects Research Recordkeeping and Record Retention April 26, 2021 04/26/21
Human Subjects Research Recordkeeping and Record Retention Jan. 19, 2021 01/19/21

Reviews

Dana D:
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Date Attended: June 9, 2021, 1:38 p.m.
Date Reviewed: June 10, 2021, 10:55 a.m.
Anonymous: Well organized and presented . Examples were very helpful. Would be helpful to have handout with examples of best practices and frequent error examples.
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Date Reviewed: June 9, 2021, 4:02 p.m.
Anonymous: Well organized and presented . Examples were very helpful. Would be helpful to have handout with examples of best practices and frequent error examples.
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Date Reviewed: June 9, 2021, 4:02 p.m.
Liane A: An admirable job presenting a very large amount of information, clearly, and concisely!
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Date Attended: June 9, 2021, 1:37 p.m.
Date Reviewed: June 9, 2021, 3:15 p.m.
Anonymous: The training was great and very informative. I do agree that this likely could be broken into a series of training since there is so much information to cover. One technical thing, which has nothing to do with the actual training: There was a repetitive click/feedback (I believe from the instructor's headphones hitting something) that I found distracting. Thank you!
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Date Reviewed: May 19, 2021, 11:30 a.m.
Anonymous: I would have like to have seen some examples of the current forms and have done a practical run through of all the steps needed to be successful. A lot of information that was well presented.
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Date Reviewed: May 19, 2021, 7:57 a.m.
Syphorn P: Excellent!
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Date Attended: May 17, 2021, 3:50 p.m.
Date Reviewed: May 18, 2021, 2:59 p.m.
Bin Z:
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Date Attended: May 17, 2021, 3:51 p.m.
Date Reviewed: May 17, 2021, 11:18 p.m.
Anonymous:
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Date Reviewed: May 17, 2021, 4:13 p.m.
Antonio A:
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Date Attended: May 17, 2021, 3:50 p.m.
Date Reviewed: May 17, 2021, 3:50 p.m.
Anonymous: Very informative. I think it a separate course could be offered as a case study of recordkeeping. Attendees could brainstorm ideas of recordkeeping systems for an example study. At the end, we would compare the actual recordkeeping system used by the example study and what we came up with. That way real-world examples would be incorporated into the presentation.
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Date Reviewed: April 26, 2021, 12:25 p.m.
Kassandra R:
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Date Attended: April 26, 2021, 10:33 a.m.
Date Reviewed: April 26, 2021, 12:13 p.m.
Anonymous:
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Date Reviewed: April 26, 2021, 10:46 a.m.
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Date Reviewed: Jan. 19, 2021, 10:36 a.m.
Anonymous: These topics are so important and I think helps meet a huge need in the research community since many of us were not taught this in school, or it was not part of the training/practice in our first labs or work experience. I would like to see more real-life examples presented. What types of documents do groups who do non-FDA trials use, or how do they modify those that are used in FDA trials? Seeing the templates is helpful but I think seeing real examples would be even more useful.
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Date Reviewed: Jan. 19, 2021, 10:31 a.m.
Qingyuan Y: I really love these courses related to clinical trials. It is really awesome. It is not only helpful for keeping records of clinical trials files according to GCP, but also helpful for keeping records of any kind of scientific studies. One suggestion that the speaker can share more examples of those commonly occurred errors they found during the audit or inspection with us if it is fine, which can help us better understand the appropriate processes to keep records related to clinical trials.
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Date Attended: Jan. 19, 2021, 9:54 a.m.
Date Reviewed: Jan. 19, 2021, 10:23 a.m.
Anonymous: I'm only giving one less star because there's SO much information, and it has to apply to so many kinds of studies. I wish there were resources specific to those of us who carry out behavioral, non-treatment studies -- it would be so helpful to have the information and requirements winnowed so that we know specifically that a certain form or requirement does not apply to those studies.
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Date Reviewed: Jan. 19, 2021, 10:23 a.m.
Anonymous: So many details to think about in the world of research. Content was clear and slides reflect important need to know (and do) key points. Agree with adding more about Veeva, otherwise presentation seemed comprehensive to the topic at hand.
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Date Reviewed: Jan. 19, 2021, 10:18 a.m.
Jordan O: This review was a great overview of information about recordkeeping. In the future, I think it would be nice to go more in-depth about specific topics, perhaps breaking this up into a series of talks. The instructor was clear, concise, and informative and I learned a lot.
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Date Attended: Jan. 19, 2021, 9:58 a.m.
Date Reviewed: Jan. 19, 2021, 10:16 a.m.
Anonymous: Instructor was very thorough and easy to follow. Highly recommend this course, especially anyone running industry trials. Wish this was a required course for all new CRCs.
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Date Reviewed: Jan. 19, 2021, 10:15 a.m.
Jenna G: This was a great presentation. I'll be asking all new CRC hires within our group to attend this course in the future, along with the QI workshop. As a research group who had a recent FDA audit and 483 issued for poor recordkeeping, this will be a must attend for the team moving forward.
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Date Attended: Jan. 19, 2021, 9:58 a.m.
Date Reviewed: Jan. 19, 2021, 10:02 a.m.