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Clinical trial notification (CTN) form user guideVersion 1.2, August 2020Therapeutic Goods AdministrationCopyright Commonwealth of Australia 2020 This work is copyright. You may reproduce the whole

How to fill out clinical trial notification form

How to fill out clinical trial notification form

1. Step 1: Obtain the clinical trial notification form from the appropriate regulatory authority or organization.
2. Step 2: Read the instructions and guidelines provided with the form thoroughly.
3. Step 3: Fill in the necessary information in the respective sections of the form.
4. Step 4: Provide accurate details about the clinical trial, such as the study title, objective, methodology, and expected outcomes.
5. Step 5: Include information about the sponsor, investigators, and any collaborating institutions.
6. Step 6: Specify the target population and recruitment criteria for participants.
7. Step 7: Mention any potential risks or side effects associated with the trial.
8. Step 8: Provide details about the funding sources and financial arrangements related to the trial.
9. Step 9: Attach any relevant documents or supporting materials, such as study protocols or informed consent forms.
10. Step 10: Review the completed form for accuracy and completeness before submission.
11. Step 11: Submit the filled-out clinical trial notification form to the designated authority or organization.
12. Step 12: Follow up with the regulatory authority or organization for any additional requirements or clarifications.

Who needs clinical trial notification form?

1. Anyone planning to conduct a clinical trial involving human participants needs to fill out a clinical trial notification form. This includes researchers, pharmaceutical companies, medical institutions, academic institutions, and other entities involved in carrying out clinical trials.

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What is clinical trial notification form?

The clinical trial notification form is a document submitted to regulatory authorities to inform them about the initiation, conduct, and completion of clinical trials involving human subjects.

Who is required to file clinical trial notification form?

Sponsors, researchers, or institutions conducting clinical trials are required to file the clinical trial notification form.

How to fill out clinical trial notification form?

To fill out the clinical trial notification form, provide details about the trial protocol, the investigational product, trial site, participant information, and ensure all required sections are completed according to the guidelines provided by regulatory authorities.

What is the purpose of clinical trial notification form?

The purpose of the clinical trial notification form is to ensure transparency, facilitate regulatory oversight, and safeguard the rights and welfare of trial participants by informing authorities about ongoing clinical research.

What information must be reported on clinical trial notification form?

The information that must be reported includes trial title, objectives, methodology, eligibility criteria, the investigational product, site locations, and contact information for the principal investigator.