Download investigator brochure - University Hospitals of Leicester

University Hospitals of Leicester NHS Trust
Department of ………………
INVESTIGATOR BROCHURE
EXAMPLE DRAFT FOR
AN IN-HOUSE PHASE IV STUDY
The Title of Study
This brochure is for the clinical investigators involved with this study. It is intended to
provide appropriate scientific data as is currently available for the Investigational
Medicinal Products (IMPs).
As new data become available, they will be incorporated into this brochure, and the
revised brochure will be forwarded to the investigators.
Drug substance:
generic name of IMP
Project No.:
UHL No.
Edition No.:
1
Supersedes edition:
Not applicable
Release Date:
……….. 2004
Document (electronic) location:
Enter electronic file reference, e.g. Smith/Clinical
R&D/UHL No/AbbrevTitleofStudy/010804
This brochure is a confidential document intended for use
only by personnel involved in this study
Draft example produced by Sarah Peck, UHL Clinical Trials Pharmacist – remove this footer for your brochure
Version 1.1 – 16 August 2004
Investigator Brochure – Version 1 - August 2004
UHL No - insert correct number here
Contents
Page
1.
Summary
2
2.
Introduction
3
3.
Drug substance (Investigational Medicinal Product)
3
3.1 Physical, chemical and pharmaceutical properties
3
3.2 Storage and handling
3
4.
Duration of follow-up period
4
5.
Effects in humans
4
5.1 Introduction
4
5.2 Pharmacokinetics and metabolism in humans
4
5.3 Efficacy
4
5.4 Safety
5
5.5 Marketing situation
5
6.
References
5
7.
Appendices
5
Appendix 1:
6
Summary of Product Characteristics
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UHL No - insert correct number here
Summary of Changes to Previous Edition
This is the first and currently, final version of the Investigator Brochure.
As new data become available, they will be incorporated into this brochure, and the
revised brochure will be forwarded to the investigator team.
Abbreviations
SPC
Summary of Product Characteristics (produced by marketing authorisation
holder for the medicinal product)
UHL
University Hospitals of Leicester NHS Trust
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1.
Summary
In developing the protocol, the investigator reviewed relevant literature and material
from previous studies. A list of these references can be found in the protocol 1.
…………………… (a ………………………) is being administered orally in this study.
The formulations being used are ‘standard’ tablets and enteric-coated tablets – both
forms are readily available commercially as UK licensed products. They are used
extensively for many different medical conditions including the treatment of
……………….. patients.
SPCs have been included as appendices to this document.
2.
Introduction
Text taken from protocol1.
3.
Drug substance (Investigational Medicinal Product)
3.1 Physical, chemical and pharmaceutical properties
The tablet strength used in this study is 5mg. To make up the required
dose, multiple tablets will need to be given.
The make of tablets kept in stock by the UHL Pharmacy Department will
be used. The standard tablets are white, flat and round. The entericcoated tablets are red, convex-shaped and round.
The SPCs are for a given ‘make’ of tablet and while this particular ‘make’
may not be stocked by the Pharmacy Department, the SPC does give an
indication of the characteristics of the product used.
3.2 Storage and handling
The tablets should be stored below 25oC. If the storage temperature rises
above 25oC, the Study Investigator should be contacted (who in turn may
need to contact the Pharmacy Department Clinical Trials Co-ordinator) for
advice.
There are no particular handling requirements. As part of accepted good
practice, the tablets should be handled as little as possible.
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4.
Duration of follow-up period
5.
Effects in humans
5.1 Introduction
……………………… is a corticosteroid with mainly glucocorticoid activity.
In this study, ……………….is ………………………………
Owing to its less pronounced mineralocorticoid activity …………………….
is less likely than cortisone or hydrocortisone to cause sodium retention,
electrolyte imbalance, and oedema3.
5.2 Pharmacokinetics and metabolism
……………………………. is readily absorbed from the gastrointestinal
tract, and is in a metabolically active form3.
Peak plasma concentrations of ……………………. are obtained 1 or 2
hours after a dose by mouth, and it has a usual plasma half-life of 2 to 4
hours. Its initial absorption, but not its overall bioavailability, is affected by
food3.
………………………….. is extensively bound to plasma proteins. The
volume of distribution, and also the clearance are reported to increase
with an increase from low to moderate doses; at very high doses,
clearance appears to become saturated3.
…………………………… is excreted in the urine as free and conjugated
metabolites, together with an appreciable proportion of unchanged
prednisolone3.
……………………….. has a biological half-life lasting several hours3.
This study is seeking to ascertain whether ………………….
.
……….. will affect the pharmacokinetics, in this particular patient group.
5.3 Efficacy
The efficacy of …………………………. is widely known. The objective of
this study though, is to ascertain whether the efficacy in
…………………….. is affected by ………………………………..
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5.4 Safety2
It is considered that the risk of potential side effects including
……………………………………………………., is ……………………..
5.5 Marketing situation
Standard and enteric-coated ………………….. tablets are licensed for use
in the UK and are readily available.
Manufacturers of ‘standard’ ………………………. tablets include2:
Alpharma Ltd
APS – Approved Prescription Services Ltd
Arrow Generics Ltd
Beacon Pharmaceuticals Ltd
CP Pharmaceuticals Ltd
Hillcross (AAH Pharmaceuticals Ltd)
IVAX Pharmaceuticals UK Ltd
Manufacturers of enteric-coated ……………………….. tablets include2:
Alpharma Ltd
APS – Approved Prescription Services Ltd
Berk Pharmaceuticals (see APS above)
Pfizer Ltd (Deltacortril Enteric®)
6.
References
1. Authors of protocol. Protocol title: ………………………….. . Department of
……………………………………., ………………, University Hospitals of Leicester
NHS Trust. 2004
2. British National Formulary. Edn 47. British Medical Association & Royal
Pharmaceutical Society of Great Britain. London. March 2004
3. Martindale: The Complete Drug Reference. ……………………….
7.
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Appendices
5