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45 CFR 164. 512 b 1 Return completed form to the CDPH STD Congenital Syphilis Coordinator via secure email to cpacs cdph. ca.gov or fax to 916. 440. 5949 CDPH 9049 4/2013 CS Case Report 4/4/2013 a. Adequate treatment in adults is defined in the STD Treatment Guidelines cdc.gov/std/treatment/. State of California Health and Human Services Agency California Department of Public Health Mother s Name CASE ID No* Mother s CalREDIE ID Infant s Name Delivery Hospital Infant s CalREDIE ID CALIFORNIA...
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How to fill out case report form
How to fill out a case report form:
01
Begin by familiarizing yourself with the purpose and structure of the case report form.
02
Ensure you have all the necessary information and documentation required to complete the form accurately.
03
Start by providing general information about the patient, such as their name, age, gender, and contact details.
04
Proceed to record the specifics of the case, including the date of onset, symptoms, medical history, and any relevant test results.
05
Describe the treatment administered to the patient, including the dosage, duration, and any observed side effects.
06
If applicable, detail any adverse events or complications associated with the treatment, along with the actions taken to manage them.
07
Ensure that all the data entered is accurate and legible, as this will be crucial for analysis and decision-making.
08
Review the completed case report form for any errors or omissions before submitting it.
09
Submit the form to the appropriate authority or department as per the established protocol.
Who needs a case report form:
01
Healthcare professionals, such as doctors, nurses, and clinical researchers, who encounter patients and need to document their cases.
02
Clinical trial investigators who need to collect and record relevant data throughout the course of a study.
03
Drug manufacturers and regulatory agencies who require case reports to monitor the safety and efficacy of medications and medical devices.
04
Medical institutions and research organizations that maintain patient databases or conduct epidemiological studies.
05
Legal and insurance entities that may require case reports to assess liability or make coverage decisions.
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What is case report form?
A case report form (CRF) is a document used in clinical trials to collect data from each participant in a systematic manner.
Who is required to file case report form?
Typically, researchers, clinical trial sponsors, and investigators involved in conducting clinical trials are required to file case report forms.
How to fill out case report form?
To fill out a case report form, one must carefully read the instructions, provide accurate data for each required field, and ensure that the information is consistent with the source documents.
What is the purpose of case report form?
The purpose of a case report form is to systematically collect and organize participant data for regulatory submission, data analysis, and to ensure the integrity of the clinical trial.
What information must be reported on case report form?
Information that must be reported on a case report form typically includes participant demographics, medical history, treatment administration details, and outcomes or adverse events.
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