今日律师风向标：
住院期间患者家属是否有权查看病历
我表弟的儿子在人民医院住院,我想查看一下病历,可是主治医生不要看,说是要拿患者身份证,去那里记录批准了才能看,这是合理的吗!我没有想去复印资料,就是想看看!
律师回复区
你好，需要身份证明。不可能想看就给你看。
以上回复，不符合你的实际情况？马上咨询在线律师！
当前在线律师：1750人
今日回复问题：6559个
相关法律咨询
相关文章推荐
共帮助过713人
共帮助过1454人
共帮助过1473人
共帮助过3765人
共帮助过1968人
最新法律咨询
相关律师推荐
法律快车 版权所有
粤ICP备号-5 增值电信业务经营许可证 （ICP）证粤B2-
客服QQ： （注：此QQ不提供法律咨询）
免费问律师"我要查病历单"的糗事
你可能感兴趣:
糗事百科为大家收集了很多的我要查病历单的糗事，各种关于我要查病历单的爆笑经历、尴尬时刻和开心视频，想持续关注我要查病历单的糗事就收藏本页吧.
扫码下载糗事百科app如果研究者拒绝让我查看患者住院病历/医院电子病历系统？
& & & & 这几年的稽查工作中，时常有人告诉我说研究者不让看电子病历系统/患者住院病历，因此我没查看这些文件，不过研究者都已经通过问诊把病史记录在V1了。但是通常情况是，一旦作为稽查员跟研究者说明原因：
1．确认患者病史，用药史；
2．确认患者是否合格
3．ICH GCP 1.21, 4.9.7, 5.15， 6.10, 合同，方案都约定了records accessible
& & & &于是研究者就打开电脑让我看EMR了。而通常你就会吃惊的发现，那些在试验里声称没住过院的，在这里都有记录；那些声称treatment naive的病人，结果都用了12年胰岛素。所以，无论研究人员如何强势，我们都应该说明利害关系，让研究者给我们record access. 如果医院不允许监查员进入EMR查阅，可以要求研究者/研究护士打开EMR帮你搜索，你可以陪同查看。而完全依赖研究者在文件中记录&我已查看医院电子病历系统，该受试者没有住院记录&以为就此高枕无忧，那么风险其实已经埋下。
& & & & 最后，给大家分享下FDA就我在澳洲某中心被拒绝查看patient records给出的回复，这篇文章已被Clinical Advisor 发表，希望大家也能从中有所感悟。谢谢！
Can FDA Inspectors Access Medical Records without Consent?
Access refused
The query describes how an auditor recently approached an investigator in order to perform a study audit. The investigator stated that although his research and private practice activities took place in the same building, they were separate corporate entities. As a result, he would not allow the auditor access to the private practice records for subjects entered into the study. He also indicated that auditors and the FDA did not have a legal right to see the private practice records, and that neither could view the records because the subjects were psychiatric patients. He added that he had undergone four previous FDA inspections and that the agency had never asked to see his private practice records for subjects in clinical studies.
The investigator told the auditor that he had copied & from his private practice & those records that he deemed relevant to support the primary diagnosis for study entry, adding that these records were available in the research charts for review. However, he would not provide the auditor with certified copies of any of his private practice records as that would represent a double standard, on the basis that he does not require certified copies of records requested from other physicians.
The auditor felt that the limited copies made available by the investigator would not necessarily provide all the information needed (eg. about concomitant medications, laboratory values or concomitant illnesses) to confirm a subject&s study eligibility. The auditor therefore contacted the FDA GCP Program to ask the following questions.
Does an FDA investigator (inspector) have a legal right to see private practice records if s/he requested them, given the commitments made by the investigator on Form FDA 1572?
Does the FDA believe that partial records deemed relevant by the investigator to support the primary diagnosis for study entry and documentation of examinations, laboratory data, etc, performed at screening represent adequate source documentation for establishing study eligibility? Or would the FDA expect the investigator to provide original or certified copies of much or all of his private practice records to document that each subject meets all entry criteria?
Would the FDA accept copies of the investigator&s private practice records as valid source documents if the investigator has not certified the copies?
FDA guidance
The FDA acknowledged that, because the study in question involved psychiatric patients, it is understandable that there are more than the usual concerns about privacy and confidentiality.
However, the investigator is incorrect when he says that the FDA does not have a legal right to review his practice records for study subjects. The FDA has the authority to review any and all relevant records that provide background information about a subject in a study that was submitted in support of marketing for a medical product.
The agency further commented that while investigators quite often maintain copies (in so-called &shadow files&) of certain records in their study files (eg. records from another institution that must maintain the originals), if the FDA conducts an inspection the inspector will expect to review at least a portion of the original source documents for such shadow files in order to verify their authenticity, even if the copies in the shadow files are certified as authentic copies. This is important because it would otherwise be relatively easy for someone to selectively copy files in such a way as to make an ineligible subject appear eligible. Since monitors and auditors are also tasked with ensuring data integrity, they too need access to the original source documents to verify that essential information is accurate and complete.
Therefore, before including a site in a study, sponsors should verify that their monitors and auditors will be allowed access to all pertinent source documents. If the investigator and/or institution will not allow this, the sponsor should not allow the study to be conducted at that site.
The agency further advised the auditor to record the fact that they were not permitted access to subject records in their report to the sponsor. Furthermore, as the auditor was unable to verify that subjects at the site were appropriately selected, the integrity of the resulting data remains in question and the sponsor should report this in any progress report and/or marketing application/submission to the FDA, so that the FDA can determine how to consider data from the site during any subsequent review.
(责任编辑：DRUGGCP.NET)
------分隔线----------------------------