Examination of Clinical Documents

1. Contact details

   Name *

   Department/Affiliation *

   Email *

   E.g. firstname.lastname@company.com

   Contact Number

   Please include your phone number if you prefer to be contacted by phone.

   Project Title *

   SFU Research Portal Project Number Available? *

    Yes

    No

   SFU Research Portal Project Number *

   Is your study a Cinical Trial ? *

   -----YesNo

   Registration Number

   Registration number at clinicaltrials.org or similar (WHO ICTRP, EU PAS Register):

   EMA-Registration Number *

   EMA (European Medicines Agency)

   Availability of grant money for service *

   -----YesNo

2. Project Description

   Information

   Please complete this form as thoroughly and accurately as possible to expedite the review process and minimize the need for follow-up questions. This will help us schedule a more efficient and productive initial consultation.

   1. Please provide a detailed overview of your project *

   Including its methodology, data collection methods(for the data protection), and expected supports (max. 1000 characters)

   <p class="western" lang="de-DE" style="line-height: 115%; margin-bottom: 0cm;">Click or tap here to enter text.</p>

   2. Initial Consultation *

   Please select all services you need (multiple choices allowed)

    Document format & content

    Regulatory Affairs

    Registration (EMA, ClinicalTrials.gov)

    Others

    Don't need consultation

   2.1. Please describe what specific support you need? *

   Please provide all relevant information the CRA needs to support your study effectively — for example, the current study status, what is your expectation, and any specific requirements.

   3. Examination of Clinical Documents Support

   This service is intended for the review of completed documents to ensure accuracy and compliance. 

   3.1. Document Review *

    Before the clinical phase of trial (Review and preparation of required documentation)

    During the clinical trial (Ongoing review and management of trial documentation)

    After completion or termination of the trial (Final review and archiving of all trial-related documents)

    Don't need support for now

   3.1.1. Please describe what specific support you need? *

   Please provide all relevant information the CRA needs to support your study effectively — for example, the current study status, what is your expectation, and any specific requirements.

   3.1.1. Please describe what specific support you need? *

   Please provide all relevant information the CRA needs to support your study effectively — for example, the current study status, what is your expectation, and any specific requirements.

   3.1.1. Please describe what specific support you need? *

   Please provide all relevant information the CRA needs to support your study effectively — for example, the current study status, what is your expectation, and any specific requirements.

   4. Are you the primary person responsible for documentation? *

   -----YesNo

   4.1. If No, please provide primary contact information

   E.g. 1. Name, Position, Email address (preferred company email)

   <p>Click or tap here to enter text.</p>

   5. Indicate your desired timeline for the completion of the clinical document support

   6. Are there any other relevant specific requirements or constraints?

   Is there anything else that should be taken into account that you would like to share?

   <p>Click or tap here to enter text.</p>

3. Summary

   Thank you for submitting your request for Clinical Document Support!

   We will review your request, and a Clinical Research Associate (CRA) will contact you within 10 business days of receiving the form to discuss your project in more detail.

   We look forward to working with you!

4. Bist Du ein Roboter?
   Bist Du ein Roboter?