Delete this Table prior to publishing WHAT IS THIS DOCUMENT? Policy This is what we want to achieve. It reflects the organisation's position on an issue and must be adhered to by all staff within the organisation. Policies must be consistent with internal (corporate and clinical governance) and external (legislation or acts) requirements and organisational objectives. All other documents describe how we want to achieve policy. Standard Operating Procedure Contains detailed, concise steps that must be followed in the specified situation. Procedures may be developed in conjunction with a guidance or template, or independently. Guidance Contains advice on Best Practice based on institutional policy, as well as background explanation as to why this is recommended. Researchers may use their own discretion as to whether they follow a guidance.
HOW TO USE THIS TEMPLATE: This template is a .dotx (template) file. To create a new document using the template, double click on the template file saved on your computer. This will open a new document (automatically named ‘Document [number]’. To edit the template document, right click on the template file saved on your local computer drive and select ‘open’. This will open the template itself, which you can edit to suit your requirements.

STANDARD OPERATING PROCEDURE (SOP) / GUIDANCE (Delete option not applicable) Title: Source Documentation Document ID: [Document ID] Version: [Version No] Applicability: [Summary of context for use] Author NAME and TITLE: [Full Name], [Job Title] The author is signing to confirm the technical content of this document Signature: Date: [insert date] Institution/Department name: [Melbourne Childrens] Reviewed and Approval These signatures confirm the reviewers agree with the technical content of the document and that this document is approved for implementation at the Melbourne Children’s. NAME and TITLE: [Full name], [Job Title] Signature: Date: [insert date] NAME and TITLE: [Full name], [Job Title] (Delete if second signature not required. Second approval to be used in cases where dual organisation approval needed e.g. RCH, University of Melbourne) Signature: Date: [insert date] This document is effective from the date of the last approval signature and will be reviewed in [three] years.
Document History
Revision	Modified by	Date of Release	Description of Change
1.0	[Author Name]	[Publication Date]	New Issue

CONTENTS

1.	PURPOSE	4

1.1.	Quality Improvement	4

1.2.	Participant Safety	4

2.	BACKGROUND	4

3.	SCOPE	4

4.	RESPONSIBILITY	4

5.	PROCEDURE	4

5.1.	Equipment and Supplies	4

5.2.	Workflow	4

5.3.	Formatting guidance	4

5.4.	Example of Subheadings	5

5.4.1.	Select a Bookmark	5

5.4.2.	Name the Bookmark	5

5.4.3.	Link to the Bookmark	5

5.4.4.	Create ScreenTip text	5

6.	CORRECTIVE ACTIONS	5

7.	GLOSSARY	5

8.	REFERENCES	17

9.	COLLABORATORS	17

10.	APPENDICES	17

10.1.	Appendix 1: [Title]	17

10.2.	Appendix 2: [Title]	17

11.	RELATED DOCUMENTS	17

PURPOSE

Why is this SOP being developed?
What is the desired outcome of this SOP?

Quality Improvement

How does this SOP ensure or improve the quality of work?

(Delete section if not applicable to your SOP)

Participant Safety

How does this SOP ensure the safety of participants?

(Delete section if not applicable to your SOP)

BACKGROUND

Required section for Guidance. Optional addition to SOPs.

(Delete section if not applicable to your SOP)

SCOPE

Elaborates on applicability as listed at the top of the document.

When does this document apply?

What are the limitations?

RESPONSIBILITY

Who is responsible in this process?

Who is driving it to reach the desired outcome?

PROCEDURE

Equipment and Supplies

If applicable eg. Lab procedures.

(Delete section if not applicable to your SOP)

Workflow

This section may link to an appendix and/or separate document which visualises the simplified workflow for quick reference

Formatting guidance

Each new step should begin with a new subheading to allow quick reference to a particular step and to speed navigation. Ensure the paragraph is kept in line with the indentation of the heading / subheading.

Each new process heading in the procedure (and the subprocess headings where applicable) should be assigned a number which increases consecutively. Subprocesses must begin with the same numbering as their parent process, followed by increasing consecutive numbers. The purpose of this is to ensure easy reference to a specific section of an SOP. See the example below.

Example of Subheadings

Example Text: Ensure that all acronyms are expanded on their first use, and that a ScreenTip ‘mouseover’ text expands the acronym in all subsequent use. Instructions on how to add ScreenTip ‘mouseover’ text are detailed in 5.4.1 – 5.4.4.

Select a Bookmark

Example text – note that the indentation is equal to that of the subheading.
Select and highlight the text or object which will expand upon the ScreenTip eg. An explanation of an acronym. Click the "Insert" tab of the ribbon. In the "Links" group, select "Bookmark."

Name the Bookmark

Example text: Type a name under “Bookmark Name.” Make sure it is short, unique, and something you will recall. Click “Add.”

Link to the Bookmark

Example text: Select and highlight the text or object where you want the ScreenTip to appear. Right click and select ‘Link’. Select ‘Place in This Document’. Select the bookmark / heading which you would like the item to link to.

Create ScreenTip text

Example text: At the top right of the popup, select ‘ScreenTip text’ and enter the desired ‘MouseOver’ text. Click OK twice. You can hover over the word ‘ScreenTip’ in this section’s heading (5.4.4) to preview how this will appear.

Note: If the user holds the ‘control’ key and clicks on the text where a ScreenTip has been applied it will take them to the location of the Bookmark (section 5.4.1 in this example).

CORRECTIVE ACTIONS

Details of steps which must be taken should the SOP not be followed.

(Delete section if not applicable to your Guidance. Must be included in SOPs)

GLOSSARY

(Delete items not applicable)

Adverse Event

Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product or other intervention. It does not necessarily have a causal relationship with this treatment.

Adverse Reaction (AR)

Any untoward and unintended response to an investigational medicinal product related to any dose administered.

Auditor

An independent person or organisation who performs a systematic and independent examination of research related activities and documents to determine whether trial related activities, documentation, and data management have been conducted according to the protocol, GCP and applicable regulatory requirements.

Case Report Form (CRF)

Data collection tool used to record all the protocol required information to be reported to the sponsor on each research/trial participant. The CRF may be paper or electronic.

Clinical Epidemiology and Biostatistics Unit (CEBU)

CEBU specialises in biostatistics, epidemiological methods and data management. The group is jointly supported by MCRI and the University of Melbourne's Department of Paediatrics to provide expertise and support in these areas to all researchers on the Melbourne Children's campus.

Clinical Monitoring Plan (CMP)

In accordance with the Integrated Addendum to ICH E6 (R1) Guideline for Good Clinical Practice E6 (R2) Section 5.18.7 (that was formerly adopted by the TGA with annotations on 8 February 2018), the Sponsor should develop a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial. This plan must describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods to be used, and the rationale for their use.

Certified Copy

A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.

Central Trial Coordinating Centre

A group of MCRI researchers organised to coordinate the planning, development, operations and conduct of an MCRI-sponsored IIT, multi-centre, clinical trial.

Clinical Research Coordinator

A research worker who works at a clinical research site under the immediate direction of a Principal Investigator, whose research activities are conducted under Good Clinical Practice guidelines. May also be called a research coordinator, study coordinator or (for clinical trials research) a clinical trial coordinator.

Clinical Research Development Office (CRDO)

CRDO provides education and training to facilitate and increase capacity for clinical and public health research across the Melbourne Children's campus. This includes the development and implementation of Standard Operating Procedures and templates to enable researchers to conduct high quality research.

Clinical Trial

The World Health Organization (WHO) definition for a clinical trial is: 'any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes'.

Clinical Trial Approval (CTA)

Formally known as Clinical Trial Exemption (CTX), one of two schemes used by the Therapeutic Goods Administration (TGA) to authorise the supply of unapproved therapeutic goods, including medicines, medical devices, and biologicals, to participants participating in clinical trials in Australia.

The CTA scheme is appropriate for trials where the reviewing ethics committee does not have access to the appropriate scientific and technical expertise to review the trial under the CTN scheme. It is generally used for high risk or novel treatments, such as gene therapy, where there is no or limited knowledge of safety.

Clinical Trial Notification (CTN)

One of two schemes used by the Therapeutic Goods Administration (TGA) to authorise the supply of unapproved therapeutic goods, including medicines, medical devices, and biologicals, to participants participating in clinical trials in Australia.

The CTN scheme is appropriate for trials where the reviewing ethics committee has enough scientific and technical expertise to review the proposed use of the unapproved therapeutic good(s). Most investigator-initiated trials would be in this category.

Clinical Trial of an Investigational Medicinal Product (CTIMP)

A Clinical Trial of an Investigational Medicinal Product (CTIMP) is a study that looks at the safety or efficacy of a medicine/foodstuff/placebo in humans, as defined by the Medicines for Human Use (Clinical Trials) Regulations 2004.

Clinical Trial Research Agreement

An agreement between the Sponsor and a participating site that sets out the rights and obligations of each party in relation to the conduct of a clinical trial.

Collaborative Research Group

An academic and/or non-commercial collaborative research group responsible for sponsoring, initiating, managing, developing, and coordinating a research study/trial.

Corrective and Preventive Action Plan

A Corrective and Preventive Action (CAPA) plan is a quality system plan and incorporates:

Identifying the issue, including scope and impact

Identifying the root cause of the issue – how/why it occurred

Identifying actions to prevent recurrence of the issue (corrective action) or, identify actions to prevent an issue from occurring (preventive action)

Documenting that the corrective actions/preventive actions were completed

Documenting that the corrective/preventive action has resolved the problem

Data Safety Monitoring Board (DSMB)

An independent and multi-disciplinary group established by the trial sponsor to review, at intervals, accumulating trial data, in order to monitor the progress of a trial and to make recommendations on whether to continue, modify or stop the trial for safety or ethical reasons.

Essential Documents

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. These documents serve to demonstrate the compliance of the Investigator, Sponsor and monitor with the standards of Good Clinical Practice (GCP) and with all applicable regulatory requirements. Filing essential documents at the Sponsor site and participating trial sites also assists with the successful management of the trial.

Food and Drug Administration (FDA)

A department of the United States of America’s federal government responsible for the control and supervision of food safety, tobacco products, dietary supplements, medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products.

Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial participants are protected.

Good Manufacturing Practice (GMP)

A set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.

A basic tenet of GMP is that:

quality cannot be tested into a batch of product

quality must be built into each batch of product during all stages of the manufacturing process.

Human Research Ethics Committee (HREC)

A body which reviews research proposals involving human participants to ensure that they are ethically acceptable and in accordance with relevant standards and guidelines. The National Statement requires that all research proposals involving human participants be reviewed and approved by an HREC and sets out the requirements for the composition of an HREC.

International Conference on Harmonisation (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.

Inclusion and Exclusion criteria

Inclusion criteria - A list of conditions, that individuals must meet, in order to be eligible to participate in the study.

Exclusion criteria - A list of conditions, any of which will exclude the person from participating in the study.

Investigator

A person responsible for the conduct of the clinical trial at a trial site. There are four types of Investigator roles used to describe Investigators with different levels of responsibility for the conduct of clinical trials. These are described below.

Associate Investigator

Any individual member of the clinical trial team designated and supervised by the Principal investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). May also be referred to as sub-investigator.

Coordinating Principal Investigator (CPI)

If a study is conducted at more than one study site, the Principal Investigator taking the additional responsibility for coordination of the study across all sites in a region is known as the Coordinating Principal Investigator (CPI). This role applies to externally sponsored studies where the Sponsor may be a collaborative research group, commercial Sponsor or an institution. The Principal Investigator at each site will retain responsibility for the conduct of the study at their site.

Principal Investigator

The PI is the person responsible, individually or as a leader of the clinical trial team at a site, for the conduct of a clinical trial at that site. As such, the PI supports a culture of responsible clinical trial conduct in their health service organisation in their field of practice and, is responsible for adequately supervising his or her clinical trial team.

The PI must conduct the clinical trial in accordance with the approved clinical trial protocol and ensure adequate clinical cover is provided for the trial and ensure compliance with the trial protocol.

Sponsor-Investigator

An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a participant. The term does not include any person other than an individual (eg, it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

Investigator-Initiated Trials (IITs)

A clinical trial which is initiated and organised by an Investigator i.e. an individual rather than a collaborative group, company, or organisation. In these cases, the Investigator will take on the role of the trial sponsor and will then be responsible for the extensive GCP and regulatory requirements associated with both the management and conduct of the trial.

Investigational Medicinal Product (IMP)

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Investigational Medical Device (IMD)

A device that is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device.

Investigator Site File (ISF)

Filing repository controlled by the site Principal Investigator. It is held at the trial site and contains all the essential documents necessary for the site trial team to conduct the trial as well as the essential documents that individually and collectively permit evaluation of the conduct of the trial at the site and the quality of the data produced.

Investigator’s Brochure (IB)

The document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product that are relevant to the study of the product in humans.

Low / Negligible Risk (LNR)

Negligible Risk:

Research in which there is no foreseeable risk of harm or discomfort, and any foreseeable risk is of inconvenience only.

Low Risk:

Research in which the only foreseeable risk is one of discomfort

Manual of Procedures (MOP)

A handbook which supplements the protocol to guide a study’s conduct and facilitate consistency in protocol implementation and data collection across participants and clinical sites. Also commonly known as Manual of Operations (MOO).

Melbourne Children’s

The campus encompassing all staff from The Royal Children’s Hospital, Murdoch Children’s Research Institute and Department of Paediatrics University of Melbourne who initiate or carry out research under one or more of these institutional affiliations.

Melbourne Children’s Trials Centre (MCTC)

Melbourne Children’s Trials Centre (MCTC) is a collaboration between the Royal Children’s Hospital, The Murdoch Children’s Research Institute, The Royal Children’s Hospital Foundation and The University of Melbourne. This Centre brings together expertise in research, clinical practice, and education and incorporates anyone who initiates or carries out research under one or more of these institutional affiliations.

Monitor

A person appointed by the Sponsor to undertake the role of monitoring for the trial. Monitors should be appropriately trained and should have the scientific and/or clinical knowledge needed to monitor the trial adequately.

Murdoch Children’s Research Institute (MCRI)

An Australian paediatric medical research institute located in Melbourne, Victoria, affiliated with the Royal Children's Hospital and the University of Melbourne. The institute has six research themes: cellular biology, clinical sciences, genetics, infection and immunity, population health, and data science.

National Health and Medical Research Council: (NHMRC)

An independent statutory body within the portfolio of the Australian Minister for Health and Ageing responsible for allocating funding for, and directing, health and medical research, ethics and advice.

Non-Compliance Report Form

Used by sites participating in MCRI-sponsored IITs to report non-compliance with protocol or GCP to the Sponsor-Investigator/CPI when their assessment suggests a serious breach has occurred.

Non-Compliance Review Form

Used by Sponsor-Investigator/CPI to review non-compliance report Forms submitted by participating sites. This form documents the review and assessment of whether the Sponsor-Investigator/CPI determines the non-compliance to meet the definition of a serious breach.

Participant

A participant is a person that is the subject of the research.

Participant Information and Consent Form (PICF)

The PICF provides information about research and its requirements so that the prospective participant can decide if they wish to take part in the research. In general, this includes the purpose, methods, demands, risks, and benefits of the research. It must provide information to participants in a concise format that they are likely to understand. It must be participant centred.

Pharmacovigilance

Process of ongoing monitoring of the safety profile, combined with the ongoing assessment and evaluation of the risk-benefit of medicines. The process is important to identify adverse reactions/adverse device effects and changes in the known safety profile.

Protocol

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.

Protocol Deviation

A protocol deviation is any breach, divergence or departure from the requirements of GCP or the clinical trial protocol.

Pseudonymisation

Replacing information which could be used to identify an individual with a pseudonym / value which does not allow the individual to be directly identified. This is distinct from anonymisation as it is usually possible to identify the subject of pseudonymised data by analysing the underlying or related data.

Recruitment

Recruitment of participants for a research project (known as a study) is the process where people are identified and contacted for further discussion, provide informed consent, are screened and (where eligible) enrolled in a study.

Reference Safety Information (RSI)

The information contained in either an investigator’s brochure or an approved Australian Product Information (or another country’s equivalent) that contains the information used to determine what adverse reactions are to be considered “expected” adverse reactions. It will also contain information on the frequency and nature of those adverse reactions.

Research Ethics and Governance Office (REG)

REG supports the HREC and institutional research governance processes at MCRI.

Research Governance Office (RGO)

The Office or coordinated function within Melbourne Children's which is responsible for assessing the site-specific aspects of research applications, make a recommendation to the CEO / delegate as to whether a research project should be granted authorisation at that site, and overseeing that authorised research at the site meets appropriate standards (research governance).

Royal Children’s Hospital (RCH)

The Royal Children’s Hospital is major specialist paediatric hospital in Victoria, the Royal Children's Hospital provides a full range of clinical services, tertiary care, as well as health promotion and prevention programs for children and young people. Its campus partners are the Murdoch Children's Research Institute and The University of Melbourne Department of Paediatrics, which are based on site at the hospital.

Statistical Analysis Plan (SAP)

A defined outline of the planned statistical methods for the analyses for a clinical trial which provides details on the scope of planned analyses, population definitions and methodology. It may be integrated into the Protocol or exist as a separate document.

Serious Adverse Event (SAE)

An adverse event is defined as serious if it:

results in death

is life-threatening

requires hospitalisation or prolongation of existing hospitalisation

results in persistent or significant disability or incapacity

is a congenital anomaly or birth defect

Other important medical events will be considered an SAE when, based upon appropriate medical judgment, they may jeopardise the research participant safety and may require medical or surgical intervention to prevent one of the outcomes listed in the above definition. This can include diagnosis of cancer.

Serious Breach

A breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree: a) The safety or rights of a trial participant, or b) The reliability and robustness of the data generated in the clinical trial. Note: this guidance's definition of serious breach differs from the definition in the Australian Code for the Responsible Conduct of Research and is about deviations from the requirements of Good Clinical Practice or the clinical trials protocol.

Significant Safety Issue (SSI)

A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability of the trial.

Source Data

Source data is the original recording of an item of data. "All information in original records and certified copies of original records or clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.” (Section 1.51, Notes for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA Comments).

Source Document

Source documents are documents which contain source data. When data is entered directly into your electronic Case Report Forms (data collection forms) or database, the Case Report Form/database becomes your source document for that information.

Sponsor

An individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study. For investigator-initiated trials, MCRI or RCH will act as the Sponsor but delegate many sponsor responsibilities to the Coordinating Principal Investigator. In this case the CPI has the role of both Sponsor and Investigator and hence the MCTC has adopted the term Sponsor-Investigator to reflect the dual role of the CPI in investigator-initiated trials.

Standard Operating Procedure (SOP)

Detailed, written instructions to achieve uniformity of the performance of a specific function.

Study Team

Refers to the extended group of people involved in a research study. This includes the investigator team and any additional members of staff who are involved in the set-up or conduct of the study e.g. research nurse, research assistants.

Suspected Breach

A report that is judged by the reporter as a possible serious breach but has yet to be formally confirmed as a serious breach by the Sponsor.

Suspected Unexpected Serious Adverse Reaction (SUSAR)

This is a serious adverse event:

Where there is at least a reasonable possibility of a causal relationship between an intervention and an adverse event (in other words the relationship of the SAE to the trial drug/device/other intervention cannot be ruled out)

and

That is unexpected, meaning that the nature or severity of the reaction is not consistent with the known scientific information (e.g. Investigator’s Brochure for an unapproved investigational product or product information document or similar for an approved, marketed product)

Therapeutic Good

In relation to the evaluation, assessment and monitoring done by the TGA, therapeutic goods are broadly defined as products for use in humans in connection with:

preventing, diagnosing, curing, or alleviating a disease, ailment, defect, or injury

influencing inhibiting or modifying a physiological process

testing the susceptibility of persons to a disease or ailment

influencing, controlling, or preventing conception

testing for pregnancy

This includes things that are:

used as an ingredient or component in the manufacture of therapeutic goods

used to replace or modify of parts of the anatomy

Therapeutic Goods Administration (TGA)

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods.

Third Party Suspected Breach Report Form

Form used by sites to directly notify the reviewing HREC of a suspected serious breach. Use of this form is uncommon but is used if the Sponsor disagrees with the site assessment that a serious breach has occurred.

Trial Coordinator

A Trial Coordinator has a significant role in the management of the clinical trial at the Sponsor level and provides leadership in clinical trial activities to ensure that the trial is completed within budget, on time and of the highest quality. A Trial Coordinator is responsible for managing the planning, implementation, and tracking of the clinical monitoring process, administration, and start-up of the clinical trial at the participating site and maintaining an overview of the conduct of the trial at sites. Some common roles and responsibilities performed by the Trial Coordinator include:

Participate in protocol development, CRF design and clinical study report writing

Guide in the creation and development of important study documents and manuals

Conduct feasibility assessments

Develop study budgets

Oversee participant recruitment

Oversee overall trial conduct

Ensure compliance of site-staff with the trials Standard Operating Procedures

Ensures compliance to all regulatory requirements both at a local and international level

Ensures compliance to all data protection requirements both at a local and international level

Ensures compliance to all safety reporting requirements both at a local and international level

Conduct team meetings and site-staff training programs

Overall responsibility of the trial

Supervise in-house clinical trial staff

Trial Master File (TMF)

Filing repository controlled by the Sponsor/Sponsor-Investigator. It is the collection of essential documents that allows the Sponsor responsibilities for the conduct of the clinical trial, the integrity of the trial data and the compliance of the trial with Good Clinical Practice (GCP) to be evaluated.

Trial Management Group (TMG)

The TMG is a group of key people at the coordinating or principal site who oversee the day-to-day conduct and progress of a clinical trial, including safety oversight activities and/or acting on advice from other individual(s) or group(s) providing safety oversight. For many investigator-initiated trials, the TMG performs the role of a TSC (see below) and/or the DSMB.

Trial Steering Committee (TSC)

Most commonly used in commercial trials and large international non‑commercial trials, a TSC is appointed by the sponsor to provide independent expert oversight for the trial. The TSC may include investigators, other experts not otherwise involved in the trial and, usually, representatives of the sponsor. Although blinded, the TSC acts as a body that takes responsibility for the scientific integrity of the protocol and the assessment of study quality and conduct.

Unexpected Adverse Reaction (UAR)

An adverse reaction, the nature or severity of which is not consistent with the Reference Safety Information (RSI).

Urgent Safety Measure (USM)

A measure required to be taken to eliminate an immediate hazard to a participant’s health or safety.

Quality Assurance (QA)

Covers all policies and systematic activities implemented within a quality system. QA ensures that data are recorded, analysed, and recoded in accordance with the protocol and GCP. The use of GCP guidelines ensures ethical and scientific quality standards for the design, conduct, recording, and reporting of HREC approved clinical trials that involve research participants.

REFERENCES

COLLABORATORS

Other departments and / or Individuals involved in developing the SOP

Departments / Job roles which are involved in ensuring the SOP is followed

APPENDICES

Appendix 1: [Title]

Appendix 2: [Title]

RELATED DOCUMENTS

[Document ID] | [Type]: [Document Name] [V#]

FOR THIS TEMPLATE:

MCTC001 | SOP: Creation of new Standard Operating Procedures V1.0

MCTC076 | Guidance: Electronic File Naming Conventions V1.0

MCTC121 | SOP: Document Management and Version Control V1.0

DOCUMENT END