Page 18 - Research Compliance Welcome Package

• In addition to the signed consent form, you must
BSWRI record retention policies.
document the consent process in record, which should include a description of any unique circumstances (e.g., a witness was required).
• Corrections should not obstruct the original data. A single line should be written through the error, and the correction initialed and dated by the person making the change.
the subject’s
• Documents must be securely stored and accessible for unanticipated audits. Record retention requirements are dependent upon the type of research you are conducting, and you should be familiar with the various timeframes addressed in
High-quality source documentation is critical for the validation of credible research data, especially when that data may result in changes in how care is delivered to patients. Research is only as good as the quality of data collected. By following these good documentation practices, you are making sure the data collected is complete, verifiable, and
accurately reflects the conduct of the study.
Maintaining the integrity of our research data is not only required from a regulatory perspective, it ultimately shows respect for our subjects who have dedicated their time and often placed themselves at risk in the hopes that their participation can help others. 
If it isn’t documented, it didn’t happen.
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If it didn’t happen, you can’t document it.
Be on the lookout! With the launch of the annual BSWH Conflict of Interests process last week, management plans are being drafted for submitted disclosures. For those of you who have yet to submit a disclosure, be sure to not miss the deadline of July 19th. In addition, the Centers for Medicare & Medicaid Services (CMS) published the Open Pay- ments Program Year 2017 data today. It is accessible at https://openpaymentsdata.cms.gov/. Physicians are en- couraged to review your information in Open Payments Database (OPD) as a reminder of your outside activities before completing your disclosure statement.
Eligibility Checklist Tips and Tricks
An eligibility checklist is a form that documents the inclusion and exclusion criteria required by a study protocol for a subject’s participation in the research. These often include a yes/no column for site staff to indicate whether or not subjects meet certain study criteria as well as references to the corroborating information that validates the criteria (e.g., test results, physician assessment).
More importantly though, an eligibility checklist is an invaluable study project tool that can help staff remember to not only verify that subjects meet each necessary criterion for study entry, but to also clearly and comprehensively document the verification process. This is important because many eligibility criterion involve test results, subjects’ self- reported data, and certain clinical determinations that can only be evaluated by a study investigator. Furthermore, best practice and even some protocols require that investigators document their verification of subject eligibility at specific time points in the project (e.g., prior to randomization).
Here are a few examples that may help you to document subject eligibility in a meaningful way:
• When criteria are based on lab values, create lines to write in the subject’s test results to reflect eligibility.
• If a criterion requires a judgement or opinion from the PI, include space for the PI to document their evaluation
such as a yes or no selection plus an area for noting any other relevant information.
• When criteria are dependent upon a subject’s self-report, create a way to document their responses, such as
check boxes indicating the circumstances in which subjects provided that information (e.g., self-reported by subject in person, via telephone, email).
Be sure to include a place for the PI or other study investigator, where appropriate, to sign and date indicating they completed their verification of subject eligibility.
Remember that eligibility checklists should be created using the most recent IRB-approved protocol’s inclusion and exclusion criteria. To obtain a copy of our eligibility checklist template, please visit our webpage. 
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