Get the free CTSI Serious Adverse Event Reporting Form - ResearchGo

Patient sticker/labelStudy number:Date of inclusion: / / OR Patient name: + Patient ID: SERIOUS ADVERSE EVENT (SAE) CRF General information Name investigator: Signature investigator:Date of report:

How to fill out ctsi serious adverse event

How to fill out ctsi serious adverse event

1. Begin by reviewing the guidelines and instructions provided by CTSI for filling out the serious adverse event form.
2. Gather all relevant information about the event, including the date, time, and location of occurrence.
3. Identify the patient or participants involved and provide their relevant demographic information.
4. Clearly describe the serious adverse event, including any symptoms, signs, or abnormal laboratory findings.
5. Provide a detailed timeline of events leading up to the adverse event.
6. Specify any actions taken after the event, such as medical interventions or changes in the study protocol.
7. Check for any additional documentation required, such as informed consent forms, medical records, or laboratory results.
8. Complete the necessary sections of the CTSI serious adverse event form, ensuring all required fields are filled out accurately.
9. Submit the completed form as per the submission instructions provided by CTSI.
10. Keep a copy of the completed form for your records and follow any further communication or reporting requirements outlined by CTSI.

Who needs ctsi serious adverse event?

1. Researchers conducting clinical trials or studies that are overseen or funded by CTSI.

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What is ctsi serious adverse event?

CTSI serious adverse event refers to a serious unexpected side effect or harmful outcome that occurs during a clinical trial.

Who is required to file ctsi serious adverse event?

The investigator or sponsor of the clinical trial is required to file a CTSI serious adverse event.

How to fill out ctsi serious adverse event?

CTSI serious adverse events are typically reported using an online reporting system provided by the regulatory authorities.

What is the purpose of ctsi serious adverse event?

The purpose of reporting CTSI serious adverse events is to ensure the safety and well-being of participants in clinical trials.

What information must be reported on ctsi serious adverse event?

Information on the nature of the adverse event, its severity, any actions taken in response, and the outcome must be reported on CTSI serious adverse events.