Author Topic: Safety Case Narrative writting  (Read 9748 times)

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Offline sohail_crf

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Safety Case Narrative writting
« on: Thu, 30 Sep 2010 »
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Hi ,

Can anybody share information on safety case narrating writting i.e how to write safety case narrative? what are general rules for it?
format etc.

Can u provide me a sample safety case narrative writting format? I would be very thankfull to u.

Thanks & Regards
sohail

Offline arun2mohan

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Re: Safety Case Narrative writting
« Reply #1 on: Mon, 22 Nov 2010 »
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A typical narrative will include following details:

•   The manner in which you were informed (patient call, at regularly scheduled study visit etc.)
•   The date and time you were informed
•   The nature of the event
•   The date and time of the event
•   Participant’s   history in the study (i.e., date when randomized onto drug, length of   time on study drug, when the last dose was taken, the last visit before   the SAE, condition at last visit before the SAE
•   Name of hospital, clinic or other institution where the participant was seen for this AE, or SAE
•   Names of labs and tests taken
•   Relevant lab results
•   Medications prescribed (include dose)
•   Discharge information (date and time, condition upon discharge)
•   Medications prescribed upon discharge
•   Follow-up plans
•   PI’s assessment of relationship between AE/SAE and protocol or study drug
•   Any other relevant information (details are important—include everything)
•   IRB Adverse Event & IND Safety Reporting Cumulative Table


Hope it would help.

Offline sohail_crf

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Re: Safety Case Narrative writting
« Reply #2 on: Tue, 23 Nov 2010 »
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Hi arun,
 
Thanks a lot. can you plz let me know about PSUR writing.
 
Regards
Sohail.

Offline linajoshi

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Re: Safety Case Narrative writting
« Reply #3 on: Fri, 26 Nov 2010 »
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For narrative writing please refer following links
www.pharmstatus.com/AE_process_manual.doc

http://owcp.lettercarriernetwork.info/Medical%20Narrative%20-%20Critical%20Elements.pdf



Periodic Safety Update Report (PSUR)

The Periodic Safety Update Report (PSUR) is required as part of the FDA Post Marketing Drug Risk Assessment (PMDRA) program.
The PSUR software is designed to track the submission of Periodic Safety Update Reports by marketed product and country.  The PSUR is a practical mechanism for summarizing interval safety data covering short periods of time and for conducting and overall safety evaluation.  It is a tool for marketing authorization holders (MAHs) to conduct systematic analyses of safety data on a regular basis.

PSUR tracks basic information such as International Birth Date (IBD), Product license number and renewal date, and the date range of the report.  Information on all indications, dosage forms, and regimens for the active substance can also be tracked as well as the affiliate requesting the report.


MHRA Guidelines for PSUR for medicinal product:
http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/PeriodicSafetyUpdateReports/index.htm

FDA guidelines

GUIDANCE FOR INDUSTRY- E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073102.pdf

***Please refer the following link of  clinicalresearchforum itself for detail information on PSUR***


http://clinicalresearchforum.com/pharmacovigilance/what-is-psur/

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