In simple word, we can say that Investigator Brochure (IB) tells all about investigational product which is in clinical stage of development, whereas clinical trial protocol tells “how to conduct the study with that investigational product
Now lets understand one by one
“Investigator Brochure enables investigators (Doctor at hospital) conducting clinical studies to know the risks and benefits associated with an investigational product.”
What are the components of Investigator Brochure?
Though it is a quite big document but can be divided in following section:
- Summary about the all the section of document
- Introduction include everything about the drug candidate being investigated
- Details about Physical, chemical, and pharmaceutical properties and formulation of Investiogation drug
- Preclinical or nonclinical studies information
- Clinical study related information
- Any special guidance regarding the use of the drug candidate.
Where I can find the guidelines?
ICH E6 (R2) section 7 provides the information about the structure of this document.
you can read and access the guidelines from the below links:
When Investigator Brochure is updated?
Ideally It should be updated annually but whenever changes are necessary, it can be updated in the document.
An IB is first required when conducting the first clinical study in human subject and but it is said that it is a living document and need to be updated as the development of drug candidate progress.
Now we understood about IB, then What is clinical trial protocol?
“Clinical trial protocol describes the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials.”
In simple words, We can say clinical trial protocol tells us “how to conduct scientifically sound, reliable and ethically compliance trials”
What are the components of a clinical trial protocols:
Like a IB it is big document, but can be divided in following section
- Summary of all the sections i.e title, Name of all the sections, page number, abbreviations, tables etc.
- Background of the study, Its design, study objectives (questions to be answered), end points (The main result that is measured at the end of a study to see if a given treatment worked)
- Detailed information about how the data will be collected, recorded, archived (record keeping) and analysed
- Detailed information about how the safety of the subject is monitored
- Other information like Ethical consideration, Finance and Insurance policy, publication and reference.
Where I can find the guidelines:
ICH E6 (R2) section 6 provides the information about the structure of this document.
When clinical trial protocol is updated?:
It is updated whenever there is any change related to conduct of the study in any way.
Most common section which demands to update the clinical trial protocols are collection, recording, analysis, safety section or other ethical reasons.
There is no set frequency for updates.
Investigator brochure and clinical trial protocols are regulatory documents and follow strict guidelines. We have just provided an overview to help freshers to understand two important documents of clinical research before starting in depth readings.
Other important readings for freshers in clinical research:
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