Get Frm47 Pregnancy On Clinical Trial Follow Up Form - Rde Research

The FRM47 Pregnancy On Clinical Trial Follow Up Form is crucial for documenting pregnancies that occur during clinical trials. This guide provides step-by-step instructions to help you efficiently complete the form online, ensuring compliance and accurate reporting.

Follow the steps to fill out the FRM47 form online.

1. Click ‘Get Form’ button to obtain the form and open it in your preferred editor.
2. In Section 1, Trial Information, fill out the required details. This includes the Sponsor, Chief Investigator, Investigator name if from another site, Study site name, EudraCT number, R&D number, and Study Title.
3. Move to Section 2, Participant Information. Indicate whether the participant is female and has become pregnant during the clinical trial, or if a male participant’s female partner has become pregnant. Confirm if the mother has given consent to follow up the pregnancy by checking 'Yes' or 'No'.
4. Proceed to Section 3, Material Information. Enter the initials, ID number (if applicable), date of birth. For male participants, also note initials, ID number, last menstrual period, and expected delivery date.
5. In Section 4, Pre-Natal Information, check off any pre-natal tests performed, such as Amniocentesis, Ultrasound, and Maternal serum AFP, and provide the results.
6. Section 5 covers Pregnancy Outcome. Indicate if the pregnancy was carried to term and, if applicable, specify the type of delivery (normal, spontaneous, planned, therapeutic) and the delivery date.
7. In Section 6, Child Outcome, describe the birth details including sex, Apgar scores, weight, and if there was a stillbirth. Record the length and head circumference of the newborn if available.
8. Finally, complete Section 7, Additional Information. Ensure that the report is signed and dated by the Investigator and Chief Investigator. Follow the instructions to email an electronic copy to the designated email address and print and send signed copies as required.

Complete the FRM47 form online today to ensure accurate and timely reporting.