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INVESTIGATIONAL PRODUCT TEMPERATURE EXCURSION FORM. (FORM L). Division of Allergy, Immunology, and Transplantation. National Institute of ...

How to fill out investigational product temperature excursion

How to fill out investigational product temperature excursion:

1. Gather all necessary information: Start by collecting all relevant data related to the temperature excursion. This includes the date and time of the excursion, the specific product involved, the location where the excursion occurred, and any mitigating actions taken.
2. Describe the temperature excursion event: Clearly and accurately detail the temperature excursion event. Specify the duration of the excursion, the range of temperatures observed, and any potential factors that may have contributed to the deviation from the specified temperature range.
3. Analyze the impact on the investigational product: Assess the potential impact of the temperature excursion on the investigational product's integrity and stability. Consider factors such as the storage conditions required by the product's labeling, the duration of the excursion, and any relevant guidelines or regulations.
4. Document any mitigating actions taken: If any actions were taken to mitigate the impact of the temperature excursion, provide a comprehensive record of these measures. This may include steps such as relocating the product to appropriate storage, assessing product quality, or initiating a temperature deviation investigation.
5. Include any required signatures and approvals: Depending on your organization's procedures and requirements, ensure that the necessary signatures or approvals are obtained for the completed investigational product temperature excursion form. This may involve the involvement of quality assurance personnel, investigators, or regulatory authorities.

Who needs investigational product temperature excursion:

1. Clinical research organizations (CROs): CROs play a critical role in conducting clinical trials and often bear responsibility for properly handling investigational products. Monitoring and documenting temperature excursions is crucial for ensuring the integrity and safety of these products.
2. Investigative sites: Investigators at research sites are responsible for complying with protocols and maintaining proper storage conditions for investigational products. They need to document temperature excursions to track any potential impact on the integrity of the products and inform relevant parties.
3. Regulatory authorities: Regulatory bodies overseeing clinical trials or pharmaceutical research rely on detailed documentation, including investigational product temperature excursions. This information helps regulatory authorities assess adherence to guidelines, evaluate product stability, and ensure patient safety.

In summary, anyone involved in clinical research, including CROs, investigative sites, and regulatory authorities, may need investigational product temperature excursion documentation to ensure compliance, product integrity, and patient safety.

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What is investigational product temperature excursion?

Investigational product temperature excursion is when the temperature of a product being studied in a clinical trial goes outside of the acceptable range.

Who is required to file investigational product temperature excursion?

The sponsor of the clinical trial is required to file investigational product temperature excursion.

How to fill out investigational product temperature excursion?

Investigational product temperature excursion should be filled out by documenting the details of the temperature excursion event, including date, time, duration, and potential impact on the product.

What is the purpose of investigational product temperature excursion?

The purpose of investigational product temperature excursion is to ensure the safety and integrity of the investigational product being studied in the clinical trial.

What information must be reported on investigational product temperature excursion?

The information that must be reported on investigational product temperature excursion includes details of the temperature excursion event, the potential impact on the product, and any corrective actions taken.