FAQ
What format are the templates?
Editable Microsoft Word and Excel files. You download them instantly after purchase.
Can I customize and brand them?
Yes. They are built to be white labeled. Add your site or SMO name, adjust to your protocol, and reuse across studies.
What standards are they built to?
ICH E6(R3) good clinical practice and the relevant 21 CFR sections. Your site is responsible for final review against your protocol and sponsor requirements.
Are these regulatory or legal advice?
No. They are operational and educational templates for research professionals. Your site owns final compliance review.
Do you update them?
Yes. They are versioned and maintained as guidance changes, including the move to ICH E6(R3).
Can I get the whole set?
Yes. The Complete Site Startup Kit bundles every template in one purchase.
What is your refund policy?
Because these are instant digital downloads, all sales are final. If anything is wrong with a file, contact us and we will make it right.