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Fda.aov MedicalDevices/ResourcesforYou/lndustrv/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 2I CFR Part 807. ME 20993-0002 July 8. 2014 Mr. Wei Wu General Engineer No. I I Huatong Rd Beijing CHINA Re K132761 Trade/Device Name Wireless Thermometer Model WT7OI Regulatory Class Class 11 Dated June 3 2014 Received June 6 2014 Dear Mr. 92. The assigned 510O k Number K132761 I1. Prepared Date Aug. 26 2013 2. Sponsor Identification Raiing...
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How to fill out case report form template
How to fill out case report form template
01
First, gather all the necessary information for the case report form template, including patient details, medical history, and clinical findings.
02
Next, open the case report form template in a document editing software or online form builder.
03
Fill in the patient's personal information, such as name, age, and contact details.
04
Provide a brief summary of the case, including the reason for the report and any relevant background information.
05
Include the medical history of the patient, including any previous illnesses, surgeries, or medications.
06
Document the clinical findings, including physical examination results, laboratory tests, and imaging studies.
07
Specify the diagnosis or tentative diagnosis based on the available information.
08
Describe the treatment given to the patient, including medications, therapies, or surgical procedures.
09
Record any adverse events or complications that occurred during the course of treatment.
10
Finally, review the completed case report form for accuracy and completeness before submitting or sharing it with the appropriate parties.
Who needs case report form template?
01
Medical researchers and scientists who conduct clinical studies may require case report form templates to collect and organize data.
02
Healthcare professionals, including doctors, nurses, and medical practitioners, often use case report forms to document individual patient cases for medical records or research purposes.
03
Pharmaceutical companies and drug developers may utilize case report forms to gather data on drug efficacy and safety in real-world patient populations.
04
Regulatory agencies, such as the FDA, may require case report forms as part of drug approval processes or post-market surveillance.
05
Medical students and trainees may be required to fill out case report forms as part of their educational curriculum or research projects.
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What is case report form template?
Case report form template is a standardized document used to collect data related to a particular case or study.
Who is required to file case report form template?
Healthcare professionals or researchers involved in a study are required to file case report form template.
How to fill out case report form template?
Case report form template should be filled out by entering relevant information in the designated fields based on the study requirements.
What is the purpose of case report form template?
The purpose of case report form template is to systematically gather data for analysis and reporting.
What information must be reported on case report form template?
Information such as patient demographics, medical history, treatment details, and outcomes must be reported on case report form template.
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