GCP Onsite Audit Quotation Guide: A Step-by-Step Breakdown

To prepare a quotation for a GCP onsite audit, follow these steps:

Determine the scope of the audit: Before you can prepare a quotation, you need to know what the audit will cover. This includes the number of sites, the number of subjects, and the type of study. You should also consider any specific requirements or concerns the sponsor may have.
Estimate the time required: Once you know the scope of the audit, you can estimate how long it will take to complete. This will depend on the size and complexity of the study, as well as the number of sites and subjects to be audited.
Consider travel and expenses: If the audit will require travel, you should include travel expenses in your quotation. This includes airfare, lodging, meals, and any other expenses associated with travel.
Determine your hourly rate: You should determine your hourly rate based on your experience and qualifications. You may want to research industry standards to ensure your rate is competitive.
Prepare a formal quotation: Once you have gathered all the necessary information, you can prepare a formal quotation. This should include a breakdown of the costs, including your hourly rate and any expenses.
Submit the quotation: Once you have prepared the quotation, you can submit it to the sponsor for review and approval. Be prepared to answer any questions they may have and be open to negotiating the terms if necessary.