Good Clinical Practice Inquiries-1572 question

上传时间:2017-06-05作者:经纬传奇

Good morning ---
Since the 1572 form is a sponsor form, I would suggest asking the sponsor but based on the limited information in your email, I believe the 1572 form can be corrected as described. Please see the information below that we have communicated to our stakeholders in the past regarding corrections to study documents.
The steps described in ICH E6 4.9.3 represent an acceptable method to make changes or corrections in study documents. The FDA recognized ICH E6: Good Clinical Practice: Consolidated Guidance, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM073122.pdf, does include the following recommendations:Section 4.9.3: "Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e., an audit trail should be maintained); this applies to both written and electronic changes or corrections (see section 5.18.4(n)). Sponsors should provide guidance to investigators and/or the investigators' designated representatives on making such corrections. Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor's designated representatives are documented, are necessary, and are endorsed by the investigator. The investigator should retain records of the changes and corrections."
Generally, the change should be crossed out with a single line, initialed, dated in real time, and explained by writing “error” without obscuring the original document.
For more complicated corrections, a note to file might be appropriate. Document your corrections with a note to file, including how you followed up with the subject.
You should follow your SOP as it relates to corrections. This will minimize inconsistencies. Make sure that the corrections you describe are in line with your institution’s policies and procedures.
You may also be interested in reviewing FDA’s 1572 form guidance. (Link below)
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf

I hope this information is helpful. Please email us again at gcp.questions@fda.hhs.govshould you have additional questions.

Kind regards!




早上好!

由于1572表是申办方的表格,基于您邮件中的信息有限,我建议咨询申办方,我相信1572表可以按照描述的进行更正。请参阅以下信息,过去我们已经就研究文件的修订向股东传达了。

对于在研究文件中进行更改或更正,ICH E6 4.9.3中描述的步骤代表了一种可接受的方法。FDA认可的ICH E6:药物临床试验质量管理规范:综合指导,可在网站http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf上获取,包含以下信息:

4.9.3节:“对CRF的任何更改或更正应当注明日期,签名并解释(如有必要),不应掩盖原始条目(即应保留稽查轨迹);这适用于书面和电子更改或更正(见第5.18.4n)节)。申办方应为研究者和/或研究者的指定代表提供这样修正的指导。申办方应该制定书面程序,以确保申办方指定代表作出的CRF的变更或更正被记录、是必须的、并得到研究者的认可。研究者应保留更改和更正的记录。”

一般来讲,更改应该用一条直线划掉,签字,签实际时间的日期,并在不掩盖原始记录的前提下,写上“错误”来解释。

对于更复杂的修正,一份说明性文件或许是恰当的。用一份说明性文件记录您的更正,包含您如何对该受试者的跟踪随访。

您应该遵循您们与修订相关的SOP,这将减少不一致的情况,确保您所做的更正符合您机构的政策和程序。

您可能也有兴趣回顾一下FDA 1572表格指南。(链接如下)

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf

我希望这些信息对您是有帮助的。如果您还有其他问题,请联系我们gcp.questions@fda.hhs.gov 

    谨致问候!

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