Clinical trial Protocol

The Clinical Trial Protocol is the basis for all clinical trials and gives detailed information about the trial. In other words it describes the course of action of the trial.

The protocol should include information such as:

The Aims and objectives of the trial
The background of the trial
The rationale for doing the trial
Design and methodology
Description of Inclusion / Exclusion Criteria
Dosage levels
Efficacy / Safety Variables
Frequency / duration of treatment
Frequency and types of a laboratory investigations
Approvals

Trial supplies
Study Records ( Source document verification frequency )
Study Auditing / Inspection
Report Writing and Publication
Investigators consent / Agreement
Study Flow chart
Declaration of Helsinki
Reporting of Adverse Events
Serious Adverse Event Reporting Form
Patient Consent Form
Patient Information Sheet
References

Published on Apr 22, 2016
Last Updated on Jun 22, 2020

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Vanessa Jones. 2021. Clinical Trials - Protocol. Medindia, viewed May 27, 2022, https://www.medindia.net/patients/patientinfo/clinicaltrials_protocol.htm.

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galbotrix

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appu10

good guidance in simple language!!!!!!!

delmon54

I want to start a cancer support group here at a village near Madurai, to conduct free medical check-ups, guide cancer patients like where they to go for treatment, whom to contact, how to go there, where they can get free treatment or where assistance could be got etc. Those who are already doing this kind of help to cancer patients can please guide me how to run a similar cancer support group in this village near Madurai. Please contact Gurumoorthi, thanks.

guest

We are a group of anti- cancer healers and counsellors , our mission being , allow the fullest co-operation of the patient with the Specialists/Physicians for reducing the side-effects, reduce pains , ease digestion etc. All that we need is a photogragh of the patient and theh details of treatments and updations to our mail i d. Don belive us until you see the effects of our hard work . 'Service to patients with big C is service to God ' our motto .

my dad has been diagonised with stage 3 lung cancer he is undergoing radiation n chemo he is 63 years,please give me some tips about what has to be done treatment was started on 2nd august 2010.

What are the side effects that occur as a result of the new treatment/ drug

Clinical Trials - Protocol

Clinical trial Protocol

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