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GUIDELINES ON APPROVAL OF CLINICAL TRIAL & NEW DRUGS Effective Date: DRAFT GUIDANCE ON APPROVAL OF CLINICAL TRIALS & NEW DRUGS DRAFT GUIDANCE This guidance document is for feedback purposes only.
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01
Start by gathering all the necessary information and materials related to the central guidelines. This may include previous versions of the guidelines, relevant policies or procedures, and any feedback or suggestions from stakeholders.
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Review the existing guidelines and identify any areas that require updates or revisions. Consider feedback from users or experts in the field to ensure the guidelines are comprehensive and up-to-date.
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Include any necessary forms, templates, or checklists that support the implementation of the guidelines. These can simplify and standardize procedures for users.
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Collaborate with relevant stakeholders, such as department heads or subject matter experts, to ensure the guidelines address the needs and concerns of the central function.
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Review the guidelines for consistency, clarity, and accuracy. Edit and proofread the document to eliminate any errors or ambiguities.
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Obtain approval from higher management or any governing bodies for the final version of the guidelines.
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Communicate the availability and significance of the guidelines to all relevant parties, including employees, contractors, or external stakeholders.

Who needs guidelines for - central:

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