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Completing the Investigational Product Temperature Excursion Form is essential for reporting temperature excursions in clinical research. This guide will help you navigate the form accurately and ensure all necessary information is provided.

Follow the steps to fill out the form effectively.

1. Select the ‘Get Form’ button to access the Investigational Product Temperature Excursion Form and open it in the editor.
2. Begin by entering the date of the excursion in the designated field. Ensure the format is correct and reflects the occurrence date accurately.
3. Fill in the protocol number, investigator of record name, clinical research site name, and clinical research site number. This information identifies the study and site handling the investigational product.
4. Record the investigational product name, strength, dosage form, package size, manufacturer, and lot number(s). This section is crucial for identifying the specific product affected by the excursion.
5. Indicate the required storage temperature and box number(s) affected. This helps in assessing the impact of the temperature excursion.
6. In the description field, clearly outline the details of the temperature excursion, including the temperatures exposed and the duration. Provide any relevant comments that may assist in the evaluation.
7. Both the pharmacist of record and the DAIT authorized monitor need to sign in their respective sections. This is to attest that the information provided is accurate and that the temperature excursion was noted during the monitoring visit.
8. Attach the site manual or an electronic temperature log to the form as required. This documentation supports your report.
9. Once all fields are completed and the necessary documents are attached, you can save changes, download, print, or share the form as needed.

Complete the Investigational Product Temperature Excursion Form online today to ensure compliance and accurate reporting.