Loading
Get Fillable Adverse Event Log
How it works
-
Open form follow the instructions
-
Easily sign the form with your finger
-
Send filled & signed form or save
How to use or fill out the Fillable Adverse Event Log online
Filling out the Fillable Adverse Event Log is an important procedure for documenting serious adverse events during clinical trials. This guide will provide you with clear and comprehensive steps to ensure accurate and effective completion of the form.
Follow the steps to complete the Fillable Adverse Event Log online:
- Press the ‘Get Form’ button to access the Fillable Adverse Event Log and open it in your preferred editor.
- Enter the participant initials in the designated field to identify the individual involved.
- Fill in the evaluation date using the format day/month/year.
- Input the study ID to correlate the adverse event with the specific research project.
- Provide the date of birth of the participant for record-keeping purposes.
- Indicate the responsible clinician’s name and date when the event started.
- Select the type of report by ticking the appropriate box (Initial, Follow-up, or Final Report).
- If applicable, document the hospital name and the date the event ceased.
- Tick all relevant boxes describing why the event is deemed serious.
- For fatal events, specify the date of death and provide details on outcomes like ongoing, resolved, or resolved with sequelae.
- Detail the serious adverse event description, including diagnosis, medication changes, investigation results, and treatment.
- Explain why the event is believed to be treatment-related.
- Specify whether the serious adverse event is related to Plasma Exchange or Glucocorticoids by selecting ‘Yes’ or ‘No’.
- If related, indicate whether the event was expected or unexpected according to the relevant protocol.
- Provide information on which treatment the SAE is considered to be due to, specifying associated drugs.
- Detail the reporting individual’s name, position, contact information, and date of reporting.
- Sign the document as the person reporting.
- After completing all sections, options to save changes, download, print, or share the form will be available.
Complete your Fillable Adverse Event Log online today to ensure safe and effective clinical trial documentation.
Adverse events are typically graded on a scale from 1 to 4, with grade 1 representing mild events and grade 4 indicating life-threatening conditions. Understanding these grades is crucial for proper documentation and response. Your Fillable Adverse Event Log can help you categorize these events accurately, ensuring clarity and aiding in decision-making for patient care.
Industry-leading security and compliance
US Legal Forms protects your data by complying with industry-specific security standards.
-
In businnes since 199725+ years providing professional legal documents.
-
Accredited businessGuarantees that a business meets BBB accreditation standards in the US and Canada.
-
Secured by BraintreeValidated Level 1 PCI DSS compliant payment gateway that accepts most major credit and debit card brands from across the globe.