Currently, there is no single set of instructions, guidelines, or requirements and more than one registry has been established. This leaves investigators wondering which trials, what information, and which registry. The registry developed and maintained by the National Library of Medicine at NIH is the most commonly used such registry and can be accessed at http://www.clinicaltrials.gov.

Who is affected by the Security Rule?
Any researcher who stores PHI electronically, including (but not limited to):

1. A single researcher who stores data in a spreadsheet, Word document, etc. on an H: drive.
2. A researcher who stores data on a personal laptop, zip drive, or other portable hard drive or non-Partners PC.
3. A researcher and co-investigators who access data on a shared drive maintained by their department or Partners IS.
4. Researchers who transmit data electronically as part of a multi-center study
5. Researchers who maintain small, medium, or large data repositories

Please review the new HIPAA Security Rule documents on the following PHRC web pages for more information: HIPAA Security Rule and Mac Security.

Summary: Register for a half-day “Plain Language” research consent form writing workshop, presented by Ann Ogletree, Senior Human Research Specialist at the PHRC. Recent participant feedback included, “…consent form on the new template (approved by the IRB with no revisions!!!),” and “It was so helpful.” An additional workshop has been added in September to accommodate demand. To register, please email Ann Ogletree and specify which dates work for you. Feel free to sign up at either campus. Seating is limited to 12 at each session, so please list all acceptable dates.

Summary: The International Conference on Harmonisation (ICH) published Good Clinical Practice (GCP) Guidelines in 1996. This session will review the ICH GCP guidelines and discuss how they affect you. This session was offered in the summer. It is being offered again due to high demand from the Partners research community. To register, visit the QI registration web page, or call 617-424-4137.

Summary: The purpose of this seminar is to discuss ethical, regulatory, and institutional issues relevant to analysis limited to human biological samples and medical records. It answers questions, like: What needs IRB review (all of these things, at least initially!)? Which research is appropriate for expedited review? What is a "secondary use" of data or samples? What information does the IRB need to review a project efficiently? It also teaches how to share your data and specimens properly, how to fill out forms for the IRB, and which pitfalls and problems to avoid. This lecture is strongly recommended for new research fellows, though all investigators and study staff will benefit. Registration will be through the MGH Clinical Research Program. Watch for a registration announcement in the coming weeks.

Summary: Inheriting a study? Handing off a study? Ensuring good record keeping is essential during periods of staff transition. This session will focus on actions you can take to ensure your study records are complete and accurate when you take on a study or before you hand it off. To register, visit the QI registration web page, or call 617-424-4137.

Summary: Monitoring is an essential activity that ensures regulatory compliance. This session will review applicable regulations and guidelines governing study monitoring and describe various types of monitoring activities for different types of studies. The QI Monitoring Checklist will be provided to each participant. Following the discussion session, QI staff will demonstrate the Program’s new on-line monitoring system for those who may be interested in using such a system. To register, visit the QI registration web page, or call 617-424-4137.

Summary: This lecture will provide important practical advice for investigators submitting protocols to the Partners Human Research Committee (PHRC/IRB). It addresses studies being reviewed by the full committee. Find out exactly what the IRB needs to review your study, and how to present your scientific, ethical, and medical information to the IRB. Understand common design flaws, pitfalls, and omissions. Learn how to avoid time-consuming deferrals and the "back and forth" communication by providing all of the relevant information at the time of initial review of your study! Registration will be through the MGH Clinical Research Program. Watch for a registration announcement in the coming weeks.

Summary: The FDA conducts more than 1000 audits annually, and investigator non-compliance has been responsible for about 70 percent of the deficiencies found. This session will provide an overview of common deficiencies cited by the FDA, as well as corrective/preventive actions you can take no matter whether you are conducting an FDA regulated study or an internally funded study. QI staff will also share their experiences regarding how to prepare for an external audit. To register, visit the QI registration web page, or call 617-424-4137.