{"id":2217,"date":"2016-01-30T10:46:23","date_gmt":"2016-01-30T09:46:23","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=2217"},"modified":"2025-05-21T11:09:11","modified_gmt":"2025-05-21T09:09:11","slug":"audit","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/audit\/","title":{"rendered":"How to prepare an audit without stress?"},"content":{"rendered":"

How to prepare an audit without stress?<\/strong><\/h1>\n
\"Finally<\/a>

Finally an audit without stress<\/p><\/div>\n

You just got the news: your center will be audited. You already feel the stress rising. When you are audited, you still have the impression of being judged; and this is from the side of the CRA as well as the side of the investigator and his team. The audit is nevertheless a continuous improvement tool because it allows taking stock in the present in order to identify weaknesses or non-compliant points. As CRA, you are there to help the center to prepare. The CSC is there to tidy the place before the big day \ud83d\ude42<\/p>\n

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We will not return to the basics of GCP, you already know them, which is your profession. We will give you other tips for this day to pass without stress. To help you, we even noted the reference texts (Ah, they are nice the girls of Clinical Research Blog<\/p>\n

Audit Rule n<\/u>\u00b0<\/u>1: An investigator workbook up to date<\/u><\/p>\n

ICH GCP 4.9.4, ICH GCP 8.2.18<\/em><\/p>\n

The investigator workbook contains all essential documents (protocol, investigator signature page, form FDA1572 up to date, Financial Disclosure signed for all participant doctors, followed letters available …). As CSC, you must make sure it is complete and up to date with all versions of documents. Indeed, this is one of the responsibilities of the investigator and, by delegation, yours. The CRA can help you by sending you the necessary documents and providing you with a list of applicable documents. Some CRAs are even super nice, they arrange it for you \ud83d\ude42<\/p>\n

Audit Rule n\u00b02: Training certificates, CV and delegation form of \u00ab\u00a0impeccable\u00a0\u00bb tasks<\/u><\/p>\n

ICH GCP 4.1.1, 4.1.3, 4.2.4<\/em><\/p>\n

It is necessary that you make sure that all your investigators were trained in all versions of the applicable protocol, and study (e.g. at the establishment), that they all have a training certificate with minimum GCP. All team members must have had training appropriate to their task. For each training, a training certificate must be signed to document it. Do not forget, in clinical research, which is not written does not exist \ud83d\ude09<\/p>\n

You can assure you that all CVs (dated and signed) of all team members are present (from the investigator, to the CSC, via the pathologist, biologist, technician, nurse, radiologist and pharmacist). Do not forget any team member. If they are involved in the study, then their CVs must be present.<\/p>\n

You can also compare the CV and the list of task delegation. Every person on this list must have a CV available and a certificate of training in the study before starting work on the project. And above all, do not forget to put the lead investigator on the list \u00a0\ud83d\ude09<\/p>\n

Audit Rule n\u00b03: The AE and SAE well documented and tidy<\/u><\/p>\n

Decision of 24 November 2006 8.3.16<\/em><\/p>\n

It is preferable that the connection between the study treatments and adverse events are properly reported in the medical record (\u00ab\u00a0possible\u00a0\u00bb, \u00ab\u00a0unbound\u00a0\u00bb, etc.) or at a minimum in a worksheet listing all adverse events. Indeed, any information found in the CRF should end up in the medical record and this one in particular. Its impact is very important for patient safety.<\/p>\n

Think well to store all SAE forms and the sending evidence (fax or email). This is not because the form is completed that it was sent \ud83d\ude42<\/p>\n

Audit Rule n\u00b04: The protocol deviations explained all<\/u><\/p>\n

ICH GCP 4.5.1, 4.5.3; Decision of 24 November 2006 8.3.11<\/em><\/p>\n

Any deviation to the protocol should be explained in the medical record. For example, in the case where patient\u2019s compliance is not complete or tablets are missing. This type of deviation must be explained on the accounting sheet or in the patient’s medical record.<\/p>\n

I recommend you to note what corrective and preventive actions have been taken to correct these deviations. The promoter should help the establishment of action and must also reform the centers, if necessary. As CRA, all additional training or information to the center should be documented to prove that the developer has followed the research as it should.<\/p>\n

Audit rule n\u00b05: Consents<\/u><\/p>\n

Decision of 24 November 2006 4.8.8. 4.8.6.<\/em><\/p>\n

If updated consents, the latest versions of consent must be signed by the patients in the study and that in time (during the visit following the reception of the new consent by the center) so they take knowledge of new safety information.<\/p>\n

The method of obtaining consent must be reported in the medical record. The \u00ab\u00a0modality\u00a0\u00bb is how the doctor obtained informed consent. A simple sentence such as: \u00ab\u00a0Consent signed today\u00a0\u00bb to document obtaining consent is not sufficient. The ideas that should be found in the medical record are:<\/p>\n