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Click ‘Get Form’ to open it in the editor.
Begin by entering the 'Date of this submission' and 'Date of Original Approval' in the designated fields. This ensures your submission is timely and accurate.
Fill in the 'IH File Number' and 'Expected Date of Completion' to provide essential project details.
Complete the sections for 'Title of Project', 'Principal Investigator', and their contact information, including address, phone number, email, and fax number.
Indicate how many participants have been screened and enrolled in the study. Be sure to answer whether there were any withdrawals and if the study is still open for recruitment.
Address any unexpected problems or adverse events related to the study, providing explanations where necessary.
Finally, ensure all required signatures are obtained from the Principal Investigator and Co-investigators before submitting your form.
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