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CONTRACT FOR OBSERVATIONAL STUDIES WITH MEDICINES FOR HUMAN USECONTRACT BETWEEN (name of the enterprise/organization/private the Sponsor of the observational study), AND THE INSTITUT CATAL D\'ONCOLOGIA
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How to fill out registration of observational studies

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How to fill out registration of observational studies

01
Step 1: Gather all necessary information about the observational study, such as the study title, objective, and hypothesis.
02
Step 2: Identify the study design and clearly define the target population for the study.
03
Step 3: Determine the primary and secondary outcomes of the study.
04
Step 4: Choose the appropriate registry to register the observational study, such as ClinicalTrials.gov or a specialized registry for observational studies.
05
Step 5: Create an account on the chosen registry and login to access the registration form.
06
Step 6: Fill out the registration form by providing all the required information, including study details, methodology, participant eligibility criteria, and data collection methods.
07
Step 7: Upload any necessary supporting documents, such as study protocols or informed consent forms.
08
Step 8: Review the completed registration form to ensure accuracy and completeness of the information provided.
09
Step 9: Submit the registration form to the registry for review and approval.
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Step 10: Once the registration is approved, make sure to periodically update the registry with any changes to the study protocol or outcomes.
11
Step 11: Monitor the study and collect data as per the registered plan.
12
Step 12: Publish the study results and include the registration number in the publication to enhance transparency and credibility.

Who needs registration of observational studies?

01
Researchers conducting observational studies in various fields, such as epidemiology, public health, social sciences, and healthcare.
02
Institutions and organizations that fund or sponsor observational studies to ensure transparency and accountability.
03
Publishers and journals that require registration as a prerequisite for publication of observational study results.
04
Ethics committees and regulatory authorities that oversee and evaluate the validity and ethical compliance of observational studies.
05
Policy-makers and healthcare professionals who rely on reliable and transparent evidence from observational studies to inform decision-making and clinical practice.

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The registration of observational studies is the process of publicly declaring the study protocol and details before conducting the research, ensuring transparency and accountability.
Researchers and institutions conducting observational studies are typically required to file registration to comply with ethical guidelines and regulatory requirements.
Filling out the registration involves completing a standardized form that includes the study's purpose, methodology, anticipated results, and other pertinent information.
The purpose of registration is to promote transparency, prevent selective reporting, enhance study credibility, and facilitate collaboration among researchers.
Information that must be reported includes study title, objectives, methodology, primary and secondary outcomes, participant demographics, and funding sources.
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