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Clinical Trials - Protocol

Written by Vanessa Jones, B.A  | Medically Reviewed by Dr. Sunil Shroff, MBBS, MS, FRCS (UK), D. Urol (Lond) on Jun 22, 2020
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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.

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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
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  • 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

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Comments

galbotrix

Hello I’m the son of a Cancer patient. I’ve 2 boxes of Inj Iscador available for cancer treatment which I could not use for my father. Iscador is a recognized therapy for Cancer treatment to balance the side effects of Chemo and other standard treatment options. Researched and manufactured in Europe, the Injections are normally prescribed by most Cancer specialist Homeopaths and a few Oncologists. These injections have to be taken regularly over a period of 2-3 months for the desired effects. But one can consult a fellow Homeopath for the exact medications. In India, these inj have to be imported from Waleda and are available only at a few select places. The available medications are 2 boxes each of Iscador Q Series 0 and 1 @ Rs. 4500/- per box. Please read : http://www.iscador.com for more details. Also consult Dr. Kasad [Mumbai] or Dr. Navneet Rastogi (Delhi) for more info. Mail me : sniphadkar@gmail.com for more details

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 .

guest

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.

guest

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

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