Application Form

3
3.2.S.1.1 Nomenclature
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//Manufacturer Name
begin ValuePickerField fldManufacture
Height = 3
AttributeName = manufacturer
begin PickListField fldManufacturerPickList
Caption = "Manufacturer"
HelpMessage = "Please select the Manufacturer from the available list."
//Filter = $QUERYCLAUSE("upper(\"text\") like upper('{0}')")
end
end
3.2.S.2.1 Manufacturer(s)
2.3.S.2 Manufacture
3.2.S.2.3 Control of Materials
Biotech:
Control of Source and Starting Materials of Biological Origin

Source, history, and generation of the cell substrate

Cell banking system, characterisation, and testing

3.2.S.2.4 Controls of Critical Steps and Intermediates
3.2.S.2.5 Process Validation and/or Evaluation
.
Biotech:
3.2.S.2.6 Manufacturing Process Development
NCE:
Biotech:
Biotech:



Biotech:



Biotech:



2.3.S.5 Reference Standards or Materials
3.2. S.6 Container Closure System
3.2.P DRUG PRODUCT
3.2.P.1 Description and Composition of the Drug Product
3.2.P.2.4 Container Closure System
3.2.P.3 Manufacture
3.2.P.3.1 Manufacturer(s)
3.2.P.3.2 Batch Formula
3.2.S.2.5 Process Validation and/or Evaluation
.
Biotech:
3.3 References
3.3.1 Reference 1
1
3.2.A APPENDICES
3.2.A.1 Facilities and Equipment
3.2.A.3 Novel Excipients
3.3 References
3.3.1 Reference 1
1
List of Abbreviations and Definitions of Terms
Introduction
The introduction should contain a brief statement (maximum: 1 page) placing the study in the
context of the development of the test drug/investigational product, relating the critical features of
the study (e.g. rationale and aims, target population, treatment, duration, primary endpoints) to
that development. Any guidelines that were followed in the development of the protocol or any
other agreements/meetings between the sponsor/company and regulatory authorities that are
relevant to the particular study, should be identified or described.
Investigational Plan
Methods
The overall study plan and design (configuration) of the study (e.g. parallel, cross-over) should be
described briefly but clearly, using charts and diagrams as needed. If other studies used a very
similar protocol, it may be useful to note this and describe any important differences. The actual
protocol and any changes should be included as appendix 16.1.1 and a sample case report form
(unique pages only; i.e. it is not necessary to include identical pages from forms for different
evaluations or visits) as appendix 16.1.2. If any of the information in this section comes from
sources other than the protocol, these should be identified.
The information provided should include:
− treatments studied (specific drugs, doses and procedures)
− patient population studied and the number of patients to be included
− level and method of blinding/masking (e.g. open, double-blind, single-blind, blinded evaluators
and unblinded patients and/or investigators)
− kind of control(s) (e.g. placebo, no treatment, active drug, dose-response, historical) and study
configuration (parallel, cross-over)
− method of assignment to treatment (randomisation, stratification)
− sequence and duration of all study periods, including pre-randomisation and post-treatment
periods, therapy withdrawal periods and single- and double-blind treatment periods. When
patients are randomised should be specified.
It is usually helpful to display the design graphically with a flow chart which includes timing of
assessments (see Annexes IIIa and IIIb for an example)
− any safety, data monitoring or special steering or evaluation committees
− any interim analyses.
Discussion
The specific control chosen and the study design used should be discussed, as necessary.
Examples of design issues meriting discussion follow. Generally, the control (comparison) groups
that are recognised are placebo concurrent control, no treatment concurrent control, active
treatment concurrent control, dose comparison concurrent control, and historical control. In
addition to the type of control, other critical design features that may need discussion are use of a
cross-over design and selection of patients with particular prior history, such as response or non-
response to a specific drug or member of a drug class. If randomisation was not used, it is
important to explain how other techniques, if any, guarded against systematic selection bias.
Known or potential problems associated with the study design or control group chosen, should be
1
discussed in light of the specific disease and therapies being studied. For a crossover design, for
example, there should be consideration, among other things, of the likelihood of spontaneous
change in the disease and of carry-over effects of treatment during the study. If efficacy was to be
demonstrated by showing equivalence, i.e. the absence of a specified degree of inferiority of the
new treatment compared to an established treatment, problems associated with such study designs
should be addressed. Specifically there should be provided a basis for considering the study
capable of distinguishing active from inactive therapy. Support may be provided by an analysis of
previous studies similar to the present study with respect to important design characteristics
(patient selection, study endpoints, duration, dose of active control, concomitant therapy etc.)
showing a consistent ability to demonstrate superiority of the active control to placebo. How to
assess the ability of the present study to distinguish effective from ineffective therapy should also
be discussed. For example, it may be possible to identify a treatment response (based on past
studies) that would clearly distinguish between the treated population and an untreated group.
Such a response could be the change of a measure from baseline or some other specified outcome
like healing rate or survival rate. Attainment of such a response would support the expectation
that the study could have distinguished the active drug from an inactive drug. There should also
be a discussion of the degree of inferiority of the therapy (often referred to as the delta value) the
study was intended to show was not exceeded. The limitations of historical controls are well
known (difficulty of assuring comparability of treated groups, inability to blind investigators to
treatment, change in therapy/disease, difference due to placebo effect etc.) and deserve particular
attention. Other specific features of the design may also deserve discussion, including presence or
absence of washout periods and the duration of the treatment period, especially for a chronic
illness. The rationale for dose and dose-interval selection should be explained, if it is not obvious.
For example, once daily dosing with a short half-life drug whose effect is closely related in time
to blood level is not usually effective; if the study design uses such dosing, this should be
explained, e.g. by pointing to pharmacodynamic evidence that effect is prolonged compared to
blood levels. The procedures used to seek evidence of "escape" from drug effect at the end of the
dose-interval, such as measurements of effect just prior to dosing, should be described. Similarly,
in a parallel design dose-response study, the choice of doses should be explained.
Conclusions
The efficacy and safety results of the study and the relationship of risks and benefits
should be briefly summarized and discussed, referring to the tables, figures, and sections
above as needed. The presentation should not simply repeat the description of results nor
introduce new results. The discussion and conclusions should clearly identify any new or
unexpected findings, comment on their significance, and discuss any potential problems
such as inconsistencies between related measures. The clinical relevance and importance
of the results should also be discussed in the light of other existing data. Any specific
benefits or special precautions required for individual subjects or at-risk groups and any
implications for the conduct of future studies should be identified. Alternatively, such
discussions may be reserved for summaries of safety and efficacy referring to the entire
dossier (integrated summaries).
Appendices
A list of articles from the literature pertinent to the evaluation of the study should be
provided.
2
SYNOPSIS
Name of Sponsor/Company: Individual Study Table (For National Authority

Referring to Part Use Only)
WonderMed Co. of the Dossier
Volume:
Name of Finished Product:
WonderMed Page:
Name of Active Ingredient:
ActiveX
Title of Study:
Investigators:
Study centre(s):
Publication (reference)
Studied period (years): Phase of development:

(date of first enrollment)
(date of last completed)
Objectives:
Methodology:
Number of patients (planned and analyzed):
Diagnosis and main criteria for inclusion:
Test product, dose and mode of administration, batch number:
Duration of treatment:
Reference therapy, dose and mode of administration, batch number

Name of Sponsor/Company: Individual Study Table (For National Authority
Referring to Part Use Only)
of the Dossier
Volume:
Name of Finished Product:
Page:
Name of Active Ingredient:
Criteria for evaluation:

Efficacy:
Safety:
Statistical methods:
SUMMARY - CONCLUSIONS
EFFICACY RESULTS:
SAFETY RESULTS:
CONCLUSION:
Date of report:
CLINICAL STUDY REPORT 1501:
AN INVESTIGATOR-BLINDED, RANDOMIZED, COMPARATIVE,

CROSS-OVER MULTICENTER STUDY OF WONDERMED VERSUS
EXERCISE IN THE PREVENTION OF HEADACHE PAIN IN
PATIENTS WITH A HISTORY OF MIGRAINES
WonderMed Co.
January 26, 2001
4 LIST OF ABBREVIATIONS AND DEFINITION OF
TERMS
A list of the abbreviations, and lists and definitions of specialized or unusual terms or
measurements units used in the report should be provided. Abbreviated terms should be
spelled out and the abbreviation indicated in parentheses at first appearance in the text.
5 ETHICS
5.1 INDEPENDENT ETHICS COMMITTEE (IEC) OR

INSTITUTIONAL REVIEW BOARD (IRB)
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5.2 ETHICAL CONDUCT OF THE STUDY

5.3 PATIENT INFORMATION AND CONSENT

6 INVESTIGATORS AND STUDY ADMINISTRATIVE
STRUCTURE
7 INTRODUCTION
8 STUDY OBJECTIVES
9 INVESTIGATIONAL PLAN
9.1 OVERALL STUDY DESIGN AND PLAN
9.2 DISCUSSION OF STUDY DESIGN, INCLUDING THE

CHOICE OF CONTROL GROUPS
9.3 SELECTION OF STUDY POPULATION
9.3.1 Inclusion Criteria
9.3.2 Exclusion Criteria
9.3.3 Removal of Patients from Therapy or Assessment
9.4 TREATMENTS
9.4.1 Treatments Administered
9.4.2 Identity of Investigational Product(s)
9.4.3 Method of Assigning Patients to Treatment Groups
9.4.4 Selection of Doses in the Study
9.4.5 Selection and Timing of Dose for Each Patient
9.4.6 Blinding
9.4.7 Prior and Concomitant Therapy
9.4.8 Treatment Compliance
9.4.9 A multicenter, randomized, placebo-controlled, double-blind, time-lagged,

sequential group, multi-dose, open-label study to evaluate the safety, tolerability,
efficacy, pharmacokinetics, pharmacodynamics, bioavailability, and bioequivalence
of β,α (beta, alpha) lipidohydroxyl amine transferase administerd concomitantly
with Wonder Drug™ (trademark) and Xdrug® (registered) in immunosuppressed,
cardiovascular diseased, renal failure, adult, male and female patients ≥ (greater
than or equal to) 18 years of age
9.5 EFFICACY AND SAFETY VARIABLES
9.5.1 Efficacy Measurements
9.5.2 Safety Measurements
9.5.3 Appropriateness of Measurements
9.5.4 Primary Efficacy Variable(s)
9.5.5 Drug Concentration Measurements
9.6 DATA QUALITY ASSURANCE
9.7 STATISTICAL METHODS AND DETERMINATION OF

SAMPLE SIZE
9.7.1 Statistical and Analytical Plans
9.7.2 Determination of Sample Size
9.8 CHANGES IN THE CONDUCT OF THE STUDY OR

PLANNED ANALYSES
10 STUDY PATIENTS
10.1 DISPOSITION OF PATIENTS
10.2 PROTOCOL DEVIATIONS
11 EFFICACY EVALUATION
11.1 DATASETS ANALYZED
11.2 DEMOGRAPHIC AND OTHER BASELINE

CHARACTERISTICS
11.3 MEASUREMENTS OF TREATMENT COMPLIANCE
11.4 EFFICACY RESULTS AND TABULATIONS OF INDIVIDUAL

DATA
11.4.1 Analysis of Efficacy
11.4.2 Statistical Analysis
11.4.3 Tabulation of Individual Response Data
11.4.4 Drug Dose, Drug Concentration, and Relationships to Response
11.4.5 Drug-Drug and Drug-Disease Interactions
11.4.6 By-Patient Displays
11.5 EFFICACY CONCLUSIONS
12 SAFETY EVALUATION
12.1 DATASETS ANALYZED
12.1 EXTENT OF EXPOSURE
12.3 ADVERSE EVENTS
12.3.1 Summary of Adverse Events
12.3.2 Display of Adverse Events

Table 1. Most Frequently Reported (>5%) Adverse Experiences by Body System and Preferred Term
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Data Source:
12.3.3 Analysis of Adverse Events
12.3.4 Listing of Adverse Events by Patient
12.4 DEATHS, SERIOUS ADVERSE EVENTS, AND OTHER

SIGNIFICANT ADVERSE EVENTS
12.4.1 Deaths
12.4.2 Serious Adverse Events
12.4.3 Other Significant Adverse Events
12.4.4 Analysis and Discussion of Deaths, Serious Adverse Events, and Other
Significant Adverse Events
12.5 CLINICAL LABORATORY EVALUATION
12.5.1 Listing of Laboratory Measurements by Patient and Each Abnormal

Laboratory Value
12.5.2 Evaluation of Individual Laboratory Parameters
12.5.2.1 Laboratory Values Over Time
12.5.2.2 Individual Patient Changes
12.5.2.3 Individual Clinically Significant Abnormalities
12.6 VITAL SIGNS, PHYSICAL FINDINGS, AND OTHER

OBSERVATIONS RELATED TO SAFETY
12.7 SAFETY CONCLUSIONS
13 DISCUSSION AND OVERALL CONCLUSIONS
14 TABLES FIGURES AND GRAPHS REFERRED TO

BUT NOT INCLUDED IN THE TEXT
15 REFERENCE LIST
DOCUMENT NO.: ITD-xxx.00 Page 1 of 8
Infrastructure Configuration Specification (ICS): GSV Virtual Machine (VM) for

TITLE: Submission Management System(SMS) InSight Viewer (Windows) Servers
SECTION: Infrastructure Qualification
electronic signature on file electronic signature on file

Approved By: IT, Infrastructure Approved By: IT, Quality, Security, and Compliance
electronic signature on file
Approved By: Regulatory Compliance
CONTENTS
1 PURPOSE ................................................................................................................................................................. 2
2 SCOPE....................................................................................................................................................................... 2
3 GENERAL INSTRUCTIONS ................................................................................................................................. 2
4 SPECIFICATIONS .................................................................................................................................................. 3
4.1 MACHINE OVERVIEW .......................................................................................................................................... 3
4.2 MACHINE IDENTIFIERS ........................................................................................................................................ 3
4.3 MACHINE IDENTIFIERS ........................................................................................................................................ 3
4.4 MACHINE – RANDOM ACCESS MEMORY (RAM)................................................................................................. 4
4.5 MACHINE – BASE COMPONENTS ......................................................................................................................... 4
4.6 MACHINE – PRIMARY NETWORK INTERFACE CARD (NIC) #1 COMPONENTS ...................................................... 4
4.7 PRIMARY NETWORK INTERFACE CARD (NIC) #1 CONFIGURATION ..................................................................... 4
4.8 MACHINE – NETWORK INTERFACE CARD (NIC) #2 COMPONENTS ...................................................................... 5
4.9 NETWORK INTERFACE CARD (NIC) #2 CONFIGURATION .................................................................................... 5
4.10 MACHINE – STORAGE COMPONENTS ................................................................................................................... 5
4.11 STORAGE CONTROLLER #1 COMPONENTS ........................................................................................................... 5
4.12 STORAGE CONTROLLER #2+ COMPONENTS ......................................................................................................... 5
4.13 STORAGE VOLUME CONFIGURATION ................................................................................................................... 6
4.14 STORAGE PARTITION CONFIGURATION................................................................................................................ 6
4.15 OPERATING SYSTEM CONFIGURATION ................................................................................................................ 6
4.16 MALWARE PROTECTION SPECIFICATIONS............................................................................................................ 7
4.17 MACHINE BACKUP SPECIFICATIONS .................................................................................................................... 7
4.18 MACHINE ABSTRACTION SPECIFICATIONS .......................................................................................................... 7
5 SPECIFICATION REFERENCES AND CONFIGURATION............................................................................ 7
6 APPROVAL OF INFRASTRUCTURE CONFIGURATION SPECIFICATION ............................................. 7
GILEAD SCIENCES - CONFIDENTIAL INFORMATION

Document No.: ITD-0xxx.00 GSV Virtual Machine (VM) for Windows ICS
Infrastructure Configuration Specification Page 2 of 8
1 PURPOSE
This Infrastructure Configuration Specification (ICS) describes the components and configuration settings
required to appropriately install and configure a computer server, related machine peripherals and software.
The ICS is part of the overall system Design Specifications and focuses primarily on the machine, operating
system, database management system, and connectivity to the network.
2 SCOPE
This ICS applies to the machine that supports application software and/or IT infrastructure service used by
Gilead Sciences.
3 GENERAL INSTRUCTIONS
The instructions in the table below explain how to complete the specification tables in Section 4.
Record reference information and/or attach documentation (e.g., photocopies, printouts, screen shots).
Attachments should bear the initials of the author with the corresponding date.
Column Description
ID The next consecutive number used to identify the specification, provided as part of the
template. This number will be used in a Traceability Matrix to ensure that the
corresponding specification will be tested in an Installation Qualification (IQ) or
Operation Qualification (OQ).
Description Description of the machine specification, provided as part of the template.
Specification Record specification values and/or ranges. If the specification does not apply to the
machine, enter “N/A” in this column.
Spec. Ref Record a number corresponding to the reference as listed in Section 5, “Specification
References.” Acceptable specification references include manufacturer’s
recommendations, best practices defined by industry technical leaders, information from
expert user communities and internal conventions set by Gilead Sciences.

4 SPECIFICATIONS
This section provides the machine specifications (ranges, limits, target values) that the machine should be
configured to meet.
4.1 Machine Overview

ID Description Specification Spec. Ref
4.1.1 Machine Hostname(s) fcsmsdbprod01 1

fcsmsdbval01
4.1.2 Machine Role (e.g., database server, fcsmsdbprod01 – Production 2

application server, router switch, Database servers.
storage, etc.) fcsmsdbval01 – Validation Database
servers.
4.1.3 Hosted System(s) SMS 1.0 2

(i.e., server name, application name)
4.1.4 Machine Location FC Data Center (Virtual) 1

(Site, Room, Bldg)
4.1.5 Machine Type Virtual 1

(Physical or Virtual)
4.2 Machine Identifiers

4.2.1 Fully Qualified Domain Name (e.g., fcsmsdbprod01.na.gilead.com 3

FCNADC01.NA.gilead.com) fcsmsdbval01.na.gilead.com
4.2.2 Hostname Alias(es) n/a

(e.g., medusa, vesta)
4.2.3 Active Directory Domain Name (e.g., NA 1

NA, EU, AP)
4.2.4 Brand and Model (e.g., Dell VMware ESX 3 1

PowerEdge 2850, Sun V440, Cisco
NetApps, Lucent)
4.3 Machine Identifiers


4.3.1 Number of Virtual CPUs (e.g., 2 2 or more 3

CPUs, cores)
4.3.2 Number of CPU cores (e.g., 4 CPU 2 or more 3

cores)
4.3.3 CPU speed and cache size 2.8 GHz Dual processor or higher 3
(e.g., 3.0 GHz, 1 MB) 1 MB cache or higher
4.4 Machine – Random Access Memory (RAM)

4.4.1 RAM quantity and type (e.g., 8 x 4 GB or higher 3

1 GB)
4.4.2 NVRAM quantity and type (e.g., 1 x n/a

128MB)
4.5 Machine – Chassis and Other Base Components

4.5.1 Bootable removable media device Virtual Floppy 1

type (e.g., floppy drive, memory card)
4.5.2 Alternate removable media device Virtual CDROM 1

type (e.g., CD/DVD drive, USB)
4.5.3 Power supply quantity and type (e.g., n/a

2 x hot swappable)
4.5.4 Switch modules type (i.e., network n/a

modules, WAN interfaces [e.g., T1,
T3], fiber modules, copper modules)
4.6 Machine – Primary Network Interface Card (NIC) #1 Components

4.6.1 Network interface card (NIC) type vmxnet 1
4.7 Primary Network Interface Card (NIC) #1 Configuration

4.7.1 n/a
NIC redundancy configuration (e.g.,

teamed, ether channel)
4.8 Machine – Network Interface Card (NIC) #2 Components

4.8.1 Network interface card (NIC) type vmxnet (if added) 1
4.9 Network Interface Card (NIC) #2 Configuration

4.9.1 NIC redundancy configuration (e.g., n/a

teamed, ether channel)
4.9.2 Reference for additional NICs 0 or more vmxnet NICs 1
4.10 Machine – Storage Components

4.10.1 Storage type (e.g., internal, DAS, SAN 1

SAN)
4.10.2 Storage controller quantity and 1xSCSI 1

type(s) (e.g., 1x SCSI, 1x FC HBA)
4.11 Storage Controller #1 Components

4.11.1 SC #1 type LSI Logic 1
4.11.2 Fiber #1 type (e.g., SX, LX) n\a
4.12 Storage Controller #2+ Components

4.12.1 SC #2 type LSI Logic (if added) 1
4.12.2 Fiber #2 type (e.g., SX, LX) n\a
4.12.3 Reference for additional storage 0 or more LSI Logic SCs 1

controllers

4.13 Storage Volume Configuration

4.13.1 Volume #1 RAID type (e.g., RAID-5, SAN 1

SAN, RAID DP)
4.13.2 Volume #1 Hard drive quantity-size 1x10GB or greater 1

(e.g., 5 x 73GB)
4.13.3 Volume #2 RAID type SAN (if added) 1
4.13.4 Volume #2 Hard drive 1x10GB or greater 1
4.13.5 Volume #3 RAID type SAN (if added) 1
4.13.6 Volume #3 Hard drive n/a
4.13.7 Reference (attachment) for additional n/a

volumes.
4.14 Storage Partition Configuration

4.14.1 Partition (Volume) #1 Storage C: Drive 10GB or greater 3

capacity
4.14.2 Partition (Volume) #2 Storage D: Drive 10GB or greater (if added) 3

capacity
4.14.3 Partition (Volume) #3 Storage n/a

capacity
4.14.4 Partition (Volume) #4 Storage n/a

capacity
4.15 Operating System Configuration

4.15.1 OS / IOS name and version Windows 2003 server 3
4.15.2 OS Patches (Service Pack / Patchset / Service Pack 1. 3

Patch bundle / etc.) (e.g., SP1, Patch

Bundle 1-17-05)
4.15.3 Reference to OS license (e.g., OES, Microsoft Enterprise Agreement 1

Microsoft Enterprise Agreement,
Cisco, Network Appliance)
4.16 Malware Protection Specifications

4.16.1 Application name and version (e.g., Symantec Antivirus 10 or greater 1

Symantec Antivirus 10.2)
4.17 Machine Backup Specifications

4.17.1 Backup client software (e.g., Veritas Veritas NetBackup 1

NetBackup)
4.18 Machine Abstraction Specifications

4.18.1 Machine abstraction interface (e.g., VMware Tools build 32039 or greater 1
VMware Tools build 32039)
5 SPECIFICATION REFERENCES AND CONFIGURATION

1. Gilead Sciences, Inc - Enterprise Infrastructure
2. Gilead Sciences, Inc - Enterprise Systems
3. Liquent InSight Viewer 2.0 Installation Configuration Guide
6 APPROVAL OF INFRASTRUCTURE CONFIGURATION SPECIFICATION
The approvers designated on page 1 of this document confirm that this Infrastructure Configuration
Specification has been reviewed and found to adequately describe the components and configuration settings
required to appropriately configure and maintain the machine based on manufacturer’s recommendations,
engineering best practices and internal Gilead conventions.

REVISION HISTORY
Revision Rev. Date Author Description of Changes
00 <see eQMS> Brandon Day New.

PATIENT 001
TREATMENT GROUP: WONDERDRUG 10 MG AB | WONDERDRUG 20 MG AB | PLACEBO AB |

TOTAL SELECTED PATIENTS: 8 | 8 | 4 |
| | |
PATIENTS WITH THE FOLLOWING PATIENTS | PATIENTS | PATIENTS |
OTHER TYPE ONE SYMPTOMS NO. (%) | NO. (%) | NO. (%) |
*********************************************************|**********************|**********************|
SYMPTOM-A 0 ( 0.0) | 0 ( 0.0) | 1 ( 25.0) |
SYMPTOM-B 1 ( 12.5) | 1 ( 12.5) | 0 ( 0.0) |
SYMPTOM-C 1 ( 12.5) | 0 ( 0.0) | 0 ( 0.0) |
SYMPTOM-D 0 ( 0.0) | 1 ( 12.5) | 0 ( 0.0) |
SYMPTOM-E 2 ( 25.0) | 0 ( 0.0) | 0 ( 0.0) |
SYMPTOM-F 1 ( 12.5) | 2 ( 25.0) | 2 ( 50.0) |
SYMPTOM-G 2 ( 25.0) | 2 ( 25.0) | 1 ( 25.0) |
SYMPTOM-H 0 ( 0.0) | 0 ( 0.0) | 0 ( 0.0) |
SYMPTOM-I 1 ( 12.5) | 1 ( 12.5) | 0 ( 0.0) |
SYMPTOM-J 0 ( 0.0) | 0 ( 0.0) | 0 ( 0.0) |
| | |
| | |
| | |
PATIENTS WITHOUT DIAGNOSES 6 ( 75.0) | 4 ( 50.0) | 1 ( 25.0) |
| | |
PATIENTS WITH DIAGNOSES 2 ( 25.0) | 4 ( 50.0) | 3 ( 75.0) |
PATIENT 002
TREATMENT GROUP: WONDERDRUG 10 MG AB | WONDERDRUG 20 MG AB | PLACEBO AB |

TOTAL SELECTED PATIENTS: 8 | 8 | 4 |
| | |
PATIENTS WITH THE FOLLOWING PATIENTS | PATIENTS | PATIENTS |
OTHER TYPE ONE SYMPTOMS NO. (%) | NO. (%) | NO. (%) |
*********************************************************|**********************|**********************|
SYMPTOM-A 0 ( 0.0) | 0 ( 0.0) | 1 ( 25.0) |
SYMPTOM-B 1 ( 12.5) | 1 ( 12.5) | 0 ( 0.0) |
SYMPTOM-C 1 ( 12.5) | 0 ( 0.0) | 0 ( 0.0) |
SYMPTOM-D 0 ( 0.0) | 1 ( 12.5) | 0 ( 0.0) |
SYMPTOM-E 2 ( 25.0) | 0 ( 0.0) | 0 ( 0.0) |
SYMPTOM-F 1 ( 12.5) | 2 ( 25.0) | 2 ( 50.0) |
SYMPTOM-G 2 ( 25.0) | 2 ( 25.0) | 1 ( 25.0) |
SYMPTOM-H 0 ( 0.0) | 0 ( 0.0) | 0 ( 0.0) |
SYMPTOM-I 1 ( 12.5) | 1 ( 12.5) | 0 ( 0.0) |
SYMPTOM-J 0 ( 0.0) | 0 ( 0.0) | 0 ( 0.0) |
| | |
| | |
| | |
PATIENTS WITHOUT DIAGNOSES 6 ( 75.0) | 4 ( 50.0) | 1 ( 25.0) |
| | |
PATIENTS WITH DIAGNOSES 2 ( 25.0) | 4 ( 50.0) | 3 ( 75.0) |

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begin ValuePickerField fldManufacture

begin PickListField fldManufacturerPickList

HelpMessage = "Please select the Manufacturer from the available list."

//Filter = $QUERYCLAUSE("upper(\"text\") like upper('{0}')")

Control of Source and Starting Materials of Biological Origin

Source, history, and generation of the cell substrate

Cell banking system, characterisation, and testing

Control of Source and Starting Materials of Biological Origin

Source, history, and generation of the cell substrate

Cell banking system, characterisation, and testing

Control of Source and Starting Materials of Biological Origin

Source, history, and generation of the cell substrate

Cell banking system, characterisation, and testing

Control of Source and Starting Materials of Biological Origin

Source, history, and generation of the cell substrate

Cell banking system, characterisation, and testing

Name of Sponsor/Company: Individual Study Table (For National Authority

Name of Active Ingredient:

Studied period (years): Phase of development:

Number of patients (planned and analyzed):

Diagnosis and main criteria for inclusion:

Test product, dose and mode of administration, batch number:

Reference therapy, dose and mode of administration, batch number

Name of Active Ingredient:

Criteria for evaluation:

AN INVESTIGATOR-BLINDED, RANDOMIZED, COMPARATIVE,

5.1 INDEPENDENT ETHICS COMMITTEE (IEC) OR

5.2 ETHICAL CONDUCT OF THE STUDY

5.3 PATIENT INFORMATION AND CONSENT

9.1 OVERALL STUDY DESIGN AND PLAN

9.2 DISCUSSION OF STUDY DESIGN, INCLUDING THE

9.3 SELECTION OF STUDY POPULATION

9.3.1 Inclusion Criteria

9.3.2 Exclusion Criteria

9.3.3 Removal of Patients from Therapy or Assessment

9.4.1 Treatments Administered

9.4.2 Identity of Investigational Product(s)

9.4.3 Method of Assigning Patients to Treatment Groups

9.4.4 Selection of Doses in the Study

9.4.5 Selection and Timing of Dose for Each Patient

9.4.7 Prior and Concomitant Therapy

9.4.8 Treatment Compliance

9.4.9 A multicenter, randomized, placebo-controlled, double-blind, time-lagged,

9.5.1 Efficacy Measurements

9.5.2 Safety Measurements

9.5.3 Appropriateness of Measurements

9.5.4 Primary Efficacy Variable(s)

9.5.5 Drug Concentration Measurements

9.6 DATA QUALITY ASSURANCE

9.7 STATISTICAL METHODS AND DETERMINATION OF

9.7.1 Statistical and Analytical Plans

9.7.2 Determination of Sample Size

9.8 CHANGES IN THE CONDUCT OF THE STUDY OR

10.1 DISPOSITION OF PATIENTS

10.2 PROTOCOL DEVIATIONS

11.1 DATASETS ANALYZED

11.2 DEMOGRAPHIC AND OTHER BASELINE

11.3 MEASUREMENTS OF TREATMENT COMPLIANCE

11.4 EFFICACY RESULTS AND TABULATIONS OF INDIVIDUAL

11.4.2 Statistical Analysis

11.4.3 Tabulation of Individual Response Data

11.4.4 Drug Dose, Drug Concentration, and Relationships to Response