Clinical Trial Document Templates

Professionally developed templates reflecting ICH-GCP principles, clinical research best practices, and practical TMF and document-control considerations.

Fully editable Word, Excel, and PowerPoint files, thoughtfully structured for practical use and easy customization to your organization's standards and specific trial requirements.

Built by clinical research professionals in Boston's biotech hub.

● Detailed, substantive templates ● Editable source files ● Instant delivery

Document catalog

Filter by document type to find what your trial needs.

How Delivery Works

No account required. Your download link appears immediately after payment and is also sent to your email.

01 · Checkout

Pay securely by card through Stripe. No account or password needed.

02 · Delivery

Once payment is confirmed, your private download link appears on the confirmation page and is sent to your email.

03 · Download

Download your editable file directly from the link. Your link remains valid for 30 days.

Clinical research graphics

Because your team survived another monitoring visit. Digital graphic packs for Slack, Zoom, and print.

About us

The Clinical Research Shop was proudly built by a team of clinical research professionals based in Boston’s biotech hub.

The idea grew from firsthand experience working with growing companies as they built their clinical development programs. We saw how valuable it is to have access to reliable, well-structured, substantive documents that provide a solid foundation for teams to adapt to their own standards and needs, helping them move their work forward without building every document from the ground up.

Our team brings extensive cross-functional experience spanning clinical operations, quality assurance, data management, biostatistics, regulatory affairs, and clinical development.

FAQ

1. How do I receive my file after purchase?

As soon as your payment is completed, a download link will appear on the confirmation page and the file(s) will also be sent to the email address provided at checkout. No account is required. The download link remains valid for 30 days, during which you can re-download your purchase if needed. Please use an email address you regularly have access to, as it will be associated with your order and used to provide your download link and purchase confirmation.

2. Who is authorized to use my purchase?

You may purchase templates as an individual for your own professional use or on behalf of an organization.

Each purchase grants a non-transferable license to the individual purchaser or purchasing organization for their own internal professional business use and clinical-trial activities. An individual purchaser may use the template in connection with their work, including customizing it for use within their organization. An organization purchasing a template may make it available to its employees, vendors, and authorized personnel for internal use.

The template, whether original or modified, may not be resold, sublicensed, redistributed, or shared outside the purchasing individual or organization. Please refer to our Terms of Use.

3. What file formats are included?

Files are provided in Microsoft Word (.docx), Excel (.xlsx), or PowerPoint (.pptx), depending on the product. The available format is displayed on each product page before purchase. All templates are fully editable source files, not locked PDFs, so you can add your own branding, headers, terminology, and content.

4. Are these documents legally or regulatorily reviewed?

These are professionally developed templates and are not a substitute for your organization's regulatory, quality, legal, or other applicable review and approval processes. Your organization is responsible for reviewing, adapting, and approving each document for its intended use before implementation and, where applicable, filing in the Trial Master File (TMF).

5. Can I request a refund?

Because these products are digital files delivered immediately after purchase, all sales are final once the download link has been issued. If you receive a file that is defective, corrupted, or materially different from its description, please contact us. We'll work with you to resolve the issue.

6. Do you offer bulk or organization-wide licensing?

We offer competitive pricing for multiple-template purchases and can put together a package tailored to your needs.

Contact us

Questions about a template, bulk pricing, or anything else? Send us a message.