Group items tagged Data - Healthcare 2.0

Marketing Jobs - 0 views

Marketing Jobs in Ahmedabad   Apply Now This Jobs...   https://jobs.docthub.com/sales-executive-J40437 https://jobs.docthub.com/territory-sales-manager-J43232 https://jobs.doct...

started by darshan_jobs on 04 Aug 23 no follow-up yet

FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Re... - 0 views

Roger Steven on 18 Mar 16

Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance. The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation". Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required. Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives

<div class="cArrow"> </div><div class="cContentInner">Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance. The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation". Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required. Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives</div>

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Doctor Jobs In Ranchi - 0 views

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started by darshan_jobs on 12 Sep 23 no follow-up yet

Gnm Nurse Jobs In Ahmedabad - 0 views

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started by darshan_jobs on 12 Sep 23 no follow-up yet

Nurse Jobs In Chennai - 0 views

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Doctor Jobs In Ludhiana - 0 views

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started by darshan_jobs on 12 Sep 23 no follow-up yet

Marketing Jobs in Ahmedabad - 0 views

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started by darshan_jobs on 09 Aug 23 no follow-up yet

Doctor Jobs in Ahmedabad - 0 views

Doctor Jobs in Ahmedabad   Apply Now This Jobs...   https://jobs.docthub.com/general-physician-J40642 https://jobs.docthub.com/radiologist-J46946 https://jobs.docthub.com/phy...

started by darshan_jobs on 04 Aug 23 no follow-up yet

Pharma Jobs In Hyderabad - 0 views

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BSc Nursing Jobs In Ahmedabad - 0 views

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Doctor Jobs In Pune - 0 views

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started by darshan_jobs on 12 Sep 23 no follow-up yet

Business Development Jobs In Ahmedabad - 0 views

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started by darshan_jobs on 04 Aug 23 no follow-up yet

Business Development Jobs In Ahmedabad - 0 views

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started by darshan_jobs on 09 Aug 23 no follow-up yet

Doctor Jobs in Ahmedabad - 0 views

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started by darshan_jobs on 09 Aug 23 no follow-up yet

Technician Jobs In Bangalore - 0 views

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started by darshan_jobs on 09 Aug 23 no follow-up yet

Pharma Jobs In Ahmedabad - 0 views

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Doctor Jobs In Amritsar - 0 views

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started by darshan_jobs on 12 Sep 23 no follow-up yet

Technician Jobs In Bangalore - 0 views

Technician Jobs In Bangalore   Visit URL and apply for jobs - https://jobs.docthub.com/senior-lab-technician-J38895 https://jobs.docthub.com/andrologist-technician-J45041 https://jobs.doct...

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started by darshan_jobs on 12 Sep 23 no follow-up yet

Medical Representative Jobs In Delhi - 0 views

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started by darshan_jobs on 09 Aug 23 no follow-up yet

Nursing Jobs In Bangalore - 0 views

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started by darshan_jobs on 09 Aug 23 no follow-up yet

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Marketing Jobs - 0 views

FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Re... - 0 views

Doctor Jobs In Ranchi - 0 views

Gnm Nurse Jobs In Ahmedabad - 0 views

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Business Development Jobs In Ahmedabad - 0 views

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