This is generally covered (or should be) under the special consent forms that participants sign to join the trial. The clinical trial consent should be adapted to cover the scope of the trial, as well as the additional disclosure requirements for: Monitor review/audit of the patient records; FDA adverse event notifications. The bulk of the trial data is de-identified anyway for statistical and regulatory submission purposes. However, I have not done a careful comparison between the ICH GCP, the FDA 21cfr11, and HIPAA Privacy for conflicts and overlaps yet. Additionally, the Business Associate and Trust Agreement issues need to be explored. But clearly, there is an issue here for more exploration relating to how HIPAA reacts in the tighter trials environment. Also I foresee training to be an interesting issue too!
I would be happy to discuss this further offline. My email address is [EMAIL PROTECTED] FYI, I have many years of clinical trial software and applications development experience, as well as trial process re-engineering under FDA & ICH regs. Please feel free to contact me regarding the above issues. Regards, Tim McGuinness, Ph.D. President HIPAA Help Now Inc. (www.hipaahelpnow.com) [EMAIL PROTECTED] phone: 305-753-4149 -----Original Message----- From: Vishnevsky, Jacob [mailto:[EMAIL PROTECTED]] Sent: Tuesday, July 16, 2002 1:38 PM To: '[EMAIL PROTECTED]' Subject: Patience Diaries Importance: High Could anybody comment on any latest development in area of patience diaries and clinical trials, in other words, there are obvious ambiguities in terms of the need for disclosures authorizations and general information protection during dairies review process and so on, Any comments are welcome Jacob Vishnevsky Stelex-TVG Two Greenwood Square, Suite 310 3331 Street Road Bensalem, PA 19020 phone: (215) 352-1133 cell:(215) 421-8539 fax: (215) 638-9333 email: [EMAIL PROTECTED] <mailto:[EMAIL PROTECTED]> -----Original Message----- From: Angie Lehman [mailto:[EMAIL PROTECTED]] Sent: Monday, July 15, 2002 4:26 PM To: '[EMAIL PROTECTED]' Subject: RE: please remove me from your listserv Thank you The WEDI SNIP listserv to which you are subscribed is not moderated. The discussions on this listserv therefore represent the views of the individual participants, and do not necessarily represent the views of the WEDI Board of Directors nor WEDI SNIP. If you wish to receive an official opinion, post your question to the WEDI SNIP Issues Database at http://snip.wedi.org/tracking/. Posting of advertisements or other commercial use of this listserv is specifically prohibited. The WEDI SNIP listserv to which you are subscribed is not moderated. The discussions on this listserv therefore represent the views of the individual participants, and do not necessarily represent the views of the WEDI Board of Directors nor WEDI SNIP. If you wish to receive an official opinion, post your question to the WEDI SNIP Issues Database at http://snip.wedi.org/tracking/. Posting of advertisements or other commercial use of this listserv is specifically prohibited. The WEDI SNIP listserv to which you are subscribed is not moderated. The discussions on this listserv therefore represent the views of the individual participants, and do not necessarily represent the views of the WEDI Board of Directors nor WEDI SNIP. If you wish to receive an official opinion, post your question to the WEDI SNIP Issues Database at http://snip.wedi.org/tracking/. Posting of advertisements or other commercial use of this listserv is specifically prohibited. The WEDI SNIP listserv to which you are subscribed is not moderated. The discussions on this listserv therefore represent the views of the individual participants, and do not necessarily represent the views of the WEDI Board of Directors nor WEDI SNIP. If you wish to receive an official opinion, post your question to the WEDI SNIP Issues Database at http://snip.wedi.org/tracking/. Posting of advertisements or other commercial use of this listserv is specifically prohibited.
