standard operating procedure for cta

Project Management AssignmentRAC – 203

RAC 203/TIPT/Project Management

Areas of Concern in CTA


INTRODUCTION SOP is a valuable tool for the preparation of a

CTA to Health Canada. It provides the procedural description of

materials and methods Provides details of appropriate quality, cost and

time constraints. It is prepared based on the principles of project

management. In general, SOP provides the user to think

through the procedure step by step and to standardize the materials, methods, cost and time.


CONTENTS OF SOP FOR CLINICAL TRIAL APPLICATION


Project CharterSOP of Clinical Trials ApplicationProject Overview Problem StatementIt is designed to provide tools and

relevant links in order to facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada

Project Description This SOP will be a tool for filling of Clinical Trial Application for Health Canada avoiding any discrepancies in understanding of documents and requirements of Health Canada

Project Goals and Objectives It is designed to provide tools and relevant links in order t o facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada. It is based on Health Canada’s Guidance for Clinical Trials.

Project Justification The information provided within this package is for clinical trials that involve the use of Pharmaceutical and/or Biological and Radiopharmaceutical drugs in human subjects.


Project CharterSOP of Clinical Trials ApplicationAssumptions Sponsors conducting clinical trials

in Canada with products that have received a Notice of Compliance with Conditions (NOC/c) are also required to file a CTA the product is outside the parameters of the authorized Notice of Compliance (NOC) or Drug Identification Number (DIN) application .

Constraints Project constraints being imposed in areas such as schedule, budget, resources, products to be reused, technology to be employed, products to be acquired, and project constraints based on the current knowledge today interfaces to other products.


Project CharterSOP of Clinical Trials ApplicationPROJECT SCOPE


Scope Planning Process


SCOPE DEFINITIONThe information provided within this package

is for clinical trials that involve the use of Pharmaceutical and/or Biological and Radiopharmaceutical drugs in human subjects.


WBS: Inputs, Tools & Techniques, Outputs


RELATIONSHIP BETWEEN STAKEHOLDERS AND THE PROJECT


Stakeholder’s Flow chart


Clinical Trial Application (CTA) A must to file Clinical Trial Application (CTA) to conduct clinical trials

in Phases I through III of Drug development and Comparative bioavailability trials. This includes applications to

conduct clinical trials involving marketed products where the proposed use of the product is outside the parameters of the authorized drugs.

A similar Health Canada review and approval process exists for clinical trials involving natural health products. Under the Natural Health Products Regulations, which came into effect on January 1, 2004.

Natural health products (NHPs) are defined as: * Vitamins and minerals

* Herbal remedies* Homeopathic medicines* Traditional medicines such as traditional Chinese medicines* Probiotics, and* Other products like amino acids and essential fatty acids.

Submissions satisfying the NHP Directorate's requirements will be issued a Notice of Authorization to commence the trial.


Clinical Trial Application (CTA)It is a mandatory requirement of Health

Canada that Sponsor must file a Clinical Trial Application (CTA) to conduct clinical trials in Phases I through III of drug development and comparative bioavailability trials.

The first step for the successfully filing of a CTA is a well-documented procedure that ensures that everyone involved is well aware of the documentation methods


TYPES OF CLINICAL TRIALS


Outline of a CTA / CTA-A


IMPORTANTIMPORTANT: Each Module should be

submitted in a separate binder.The modules are organized and numbered

consistently in an internationally adopted format - the Common Technical Document (CTD). Adhering to the CTD format facilitates evaluation by Health Canada and ensures consistency of documents in subsequent stages of the drug authorization process. Additional information about the CTD format is available on the web site of the International Conference on Harmonisation (ICH) at www.ich.org.

The CTA should be sent directly to the appropriate Directorate. The outer label should be clearly state "Clinical Trial Application".


Planning of Alternative Process


Barriers to introduction of new medical product


COST ESTIMATION


Project Cost Management overview


COST : WORK BREAKDOWN STRUCTURE


MILESTONE LIST


Cost Control Chart


Three modules for CTA

IMPORTANT: Each Module should be submitted in a separate binder.

The modules are organized and numbered consistently in an internationally adopted format - the Common Technical Document (CTD). Adhering to the CTD format facilitates evaluation by Health Canada and ensures consistency of documents in subsequent stages of the drug


PROJECT QUALITY MANAGEMENTProject quality management ensures that the

project satisfies the stated or implied Level of quality and the key out puts of

quality management includes:1. Quality Management Plan2. Quality matrices3. Quality Check list


QUALITYGood manufacturing practices: main

principles for pharmaceutical products Quality management in the drug industry:

philosophy and essential elements Heating Ventilation and air-conditioning

systems for non-sterile pharmaceutical dosage forms

Validation Water for pharmaceutical use


QUALITY. Good manufacturing practices: starting

materials Active pharmaceutical ingredients (bulk drug

substances) Pharmaceutical excipients


QUALITYInspection Pre-approval inspections Inspection of pharmaceutical manufacturers Inspection of drug distribution channels Quality systems requirements for national

good manufacturing practice inspectorates Guidance on good manufacturing practices:

Inspection report Model certificate of good manufacturing

practicesRAC 203/TIPT/Project Management

QUALITYGood manufacturing practices: specific

pharmaceutical products Sterile pharmaceutical products Biological products Investigational pharmaceutical products for

clinical trials in humans The manufacture of herbal medicines Radiopharmaceutical products


QUALITYHazard and risk

analysis in pharmaceutical products

Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals.

Sampling operations

Sampling of pharmaceutical products and related materials


Defined Conditions for Impact Scales of risk on Major Project Objectives


SOPs and Records(a) Equipment assembly and validation;(b) Analytical apparatus and calibration;(c) Maintenance, cleaning and sanitization;(d) Personnel matters including qualification,

training, clothing and hygiene;(e) Environmental monitoring;(f ) Pest control;(g) Complaints;(h) Recalls;(i) Returns.


SOPs and RecordsSOP for the internal labelling, quarantine and

storage of starting materials, packaging materials and other material.

SOP should be available for each instrument and piece of equipment (e.g. use, calibration, cleaning, maintenance) .

Standard operating procedures for sampling.SOP with details of the batch (lot) numbering

systemBatch-number allocation should be immediately

recorded, e.g. in a logbook. RAC 203/TIPT/Project Management

SOPs and RecordsAnalysis records should include at least the

following data: (a) The name of the material or product and, where applicable,

dosage form; (b) The batch number and, where appropriate, the manufacturer

and/or supplier; (c) References to the relevant specifications and testing procedures; (d) Test results, including observations and calculations, and

reference to any specifications (limits); (e) Date(s) and reference number(s) of testing; (f ) The initials of the persons who performed the testing; (g) The date and initials of the persons who verified the testing and

the calculations, where appropriate; (h) A clear statement of release or rejection (or other status decision)

and the dated signature of the designated responsible person.RAC 203/TIPT/Project Management

SOPs and RecordsThe records of the receipts should include: (a) The name of the material on the delivery note and the

containers; (b) The “in-house” name and/or code of the material if

different from (a); (c) The date of receipt; (d) The supplier’s name and, if possible, manufacturer’s

name; (e) the manufacturer’s batch or reference number; (f ) The total quantity, and number of containers received; (g) The batch number assigned after receipt; (h) Any relevant comment (e.g. state of the containers).


standard operating procedure for cta

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