Document Control



STANDARD OPERATING PROCEDURE

DOCUMENT CONTROL

|SOP Number |Insert SOP Reference Number |

|Version Number |1.0 |

| |NAME |TITLE |SIGNATURE |DATE |

|Author |Simon Kerridge |QA Manager | |17/May/2010 |

|Reviewer | | | | |

|Authoriser | | | | |

| |Issue Date: | |

| |Effective Date: | |

| |Review Due: | |

version History

|Previous version|Significant changes from previous version |Author |Date |

| | | | |

| | | | |

| | | | |

| | | | |

| | | | |

This SOP should be used as a guide by each CTU to ensure an appropriate document control process is implemented. It is recognised that individual units differ in size and scope. Each CTU should consider what documents it produces and who will use them with the ultimate aim of ensuring that whatever document is used is fit for purpose and accessed by those individuals who need to use it.

purpose

This SOP describes the range of controlled documents that may be produced or used by clinical trials units (CTUs) and how such documents may be managed to ensure they are fit for purpose and are accessible when needed.

Scope

This SOP applies to all documents developed by the CTU name and to all CTU staff, investigators and research teams working on CTU supported studies that are responsible for using and managing documents for clinical research.

introduction

Good documentation and document control is essential for ensuring the safety of participants and the quality of data in clinical trials. It must be possible to track any document used in any part of the trial to demonstrate approved, current procedures were used by trained staff. All documents must also be prepared to meet regulatory and local requirements.

Controlled documents include administrative, clinical and data management documents which meet the criteria for essential documents as described in the ICH Guidelines for Good Clinical Practice (1) e.g. protocols, participant information sheets (PIS) and informed consent forms (ICF), GP letters, advertisements, and data collection media including case report forms.

In addition, non-study specific documents such as policies, standard operating procedures, forms, QC and QA data and risk assessments should be controlled to an appropriate level.

Different types of documents will need different levels of control. Some documents may not be formally controlled (e.g. staff CVs) however, procedures should be in place to ensure these are updated regularly and only current versions are accessible. For other documents (e.g. Participant information sheet) it is essential that only the current approved version is used, otherwise key information may not be communicated. For these, a higher level of control is required.

The appropriate document control procedure should be applied to all documents produced by the CTU. For documents generated externally (e.g. guidelines or organisational policies, commercially sponsored study protocols) it is important to ensure that current versions are available, although it may not be necessary to incorporate all external documents into a control process.

The key elements of controlling documents are described below, and include:

• standardised formats to improve consistency of use

• author and approval processes

• version control and numbering

• training, issue and distribution

• review

• access, security, storage and archiving

• master list of documents

• responsibilities

Systems used to control documents will vary according to the needs of the unit. They will range from simple, paper based systems to databases or more complex commercially provided software solutions. The range of documents that must be controlled is extensive and several systems are likely to be employed.

ABBREVIATIONS

1 Acronyms and abbreviations

SOP Standard Operating Procedure

QA/QC Quality Assurance/Quality Control

GP General Practice/Practitioner

2 Definitions

Controlled document Written or electronic information or templates that are used to convey or record information and that are approved, reviewed and made available to staff. A document must be controlled if an unapproved change may result in a process being performed incorrectly.

For the purposes of this SOP, the term document refers to a controlled document, unless specifically stated.

Document Controller An individual who has the responsibility of ensuring controlled documents are managed according to this Document Control SOP. This may be a QA manager or similar for non-study related documents and/or a senior member of the study team for study specific essential documents.

Essential Document Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

Policy A statement that communicates the intent, objectives, requirements, responsibilities, and standards for an organisation

Procedure A particular method for performing a task.

Form A document that defines the range of data to be collected and allows entry of that data.

User Any individual who uses and applies the information in a controlled document to perform a particular procedure.

Review A checking process, performed by an expert (the reviewer) in the procedure that ensures the document is fit for purpose.

Approval A process whereby a document is certified as ready to be used.

Issue A process whereby an approved document is made available to users.

Responsibilities

Chief/Principal Investigator Must ensure that all controlled documents required for the clinical research study are accessible and fit for purpose, and are appropriately managed and controlled.

Document Controller Must ensure that all controlled documents related to clinical research are:

a) Approved and follow the guidelines for version control and naming of documents and are in the correct format.

b) Implemented within the CTU and that staff are appropriately trained in the use of the documents. Training will usually be performed by the author or other suitably qualified staff.

c) Reviewed at regular intervals and remain fit for purpose.

d) Accessible to all users when required and are being followed.

All staff Must ensure they are trained to perform the process outlined in a document, and that this training is documented. Staff should not deviate from a procedure. If staff become aware that a document is out of date or inaccurate, they must report this to the author/owner or Document Controller.

PROCEDURE

1 Types of Documents

Each unit should record the types of documents that they control, where they are stored, who is responsible for them, and how frequently they should be reviewed. Examples are provided in the table below.

The following documents are held at the CTU name.

|Document Type |Location |Responsibility (Department) |Review Period |

|Policies |Central office |Administration |Annual |

|Study documents |Site files |Study team |Dependent on study activity but |

| | | |related documents should be |

| | | |reviewed together |

|SOPs |Point of use |Quality Manager |Biennially |

| |Master copy held in | | |

| |central office | | |

|Forms |As SOPs |As SOPs |Biennially |

|Records/Results |Study files |Study team |Prior to release to sponsor or |

| | | |annually for staff records |

|Databases |Local network servers |Data manager/IT support |At each software update |

|Reference documents |Central office |Quality Manager |Document controller should receive|

| | | |update information in real time |

|Equipment manuals |With equipment |Equipment owner |Annual service |

Externally produced documents

Many documents used in clinical research are likely to have been produced by external authors/ organizations e.g. guidelines (e.g. ICH GCP), equipment manuals and Trust or University policies. It is important that current versions of such documents are accessible and that they are subject to similar control processes as other documents so that updated versions are obtained and staff are aware of updated information.

Such documents may have a different numbering system depending on their origin. It may be appropriate to simply record a list of the types of external documents and their locations (e.g. User manuals – stored with equipment). Alternatively, such documents may be given an internal CTU number which complies with the unit’s document control procedure.

The local CTU should record here the process for ensuring that externally produced documents are current and accessible.

2 Version Control and Numbering

All documents must comply with a standard numbering system to ensure that only current versions are used. The version number and title must be consistent throughout the document. The version numbering system for the CTU name is set out below.

Each CTU should record details of their version numbering system here. Different systems may be used for a) study specific essential documents and b) SOPs, policies, forms and templates provided these are clearly defined and consistent within each set. Examples of systems are:

• The version number is in the format of X.Y (e.g. 1.0). New documents, and those that are only updated at their scheduled review or have major updates, have whole number version numbers starting with 1.0. During review or development of a new document, draft versions are numbered 0.1, 1.1 etc with subsequent redrafts being increased to the next decimal (0.2, 0.3, 1.2, 1.3 etc.).

• Each version is identified as ‘Version dated…..’ and may also be further differentiated with the words ‘DRAFT, CURRENT’ etc.

SOPs and policies should contain a summary of changes made from previous versions. This may be in the form of a table of tracked changes on a word document, or a subsection for revision history. Study specific essential documents will usually be updated using tracked changes and the superseded version retained.

All documents for internal use may be annotated with identification of their status (e.g. Draft, Effective/Controlled copy, Not in use/Obsolete). For electronic copies this can be done using the watermark facility. Hard copies should be marked on each page. Alternatively, the version numbering system used may identify current or draft copies (e.g. whole number versions for current documents, decimal numbering for draft copies).

Naming of electronic documents

When saving documents as electronic files, the filename should accurately reflect the document title, using abbreviations and acronyms only if clear. The filename should provide sufficient information to identify the document including the version (this may be by adding the version number and/or date to the filename).

It is not advisable to use the Microsoft Word versioning tool as it substantially increases the size of the document which wastes valuable server space.

3 Essential Information

All documents should have the following information available either on the front page or as a header/footer on each page:

• Department/Unit name

• Names of individuals responsible for document (author/owner/approver)

• Page number

• Title, document number or code and version number – these should ensure that every document is uniquely identifiable.

• The effective date may be added to documents if appropriate (e.g. SOPs, policies)

Note: For some study documents (e.g. GP letters) it may not be appropriate to record all this information on the actual document. In such situations, the responsibilities and process should be clearly defined in this SOP or specific SOPs (e.g. Participant Information SOP).

4 author and approval process

Documents should always be written by qualified personnel with expertise in the area of the document. Templates should be used for writing SOPs and study protocols. If templates are not available, SOPs should document required content.

Draft documents should be circulated for peer and quality review before the document can be approved. The approver should be a line manager or higher, with the experience and knowledge of the process to enable them to permit the document’s use.

CTU to record here those responsible for writing and approving documents and the process involved. This should include how approval is recorded (e.g. signatures, electronically, confirmation by email). Lower level documents (e.g. forms) may require less review and approval and these should be identified here.

5 training, issue and Distribution

Before a new or revised document can be used, all users must be made aware of and, if necessary, be trained in, the new version. All relevant staff must be able to demonstrate that they are competent to use the procedure outlined in the document. Document training methods and how these events are recorded are outlined in separate training procedures, but will range from simple notification (e.g. reviewed, but unchanged SOPs, forms) through a requirement to read only (policies etc.) to competency testing (SOPs, consent etc.). See also SOP: Training.

The relevant document controller will ensure that each document is made available for training following approval and prior to issue. Once existing staff have been trained, the document will become effective (a specific date should be identified from which point the new procedure replaces the old). At this time, all existing copies (if applicable) should be replaced with the new version.

6 Review process

All controlled documents are reviewed prior to first issue, when initial drafts are circulated. Major changes in content should be recorded (in the document if possible).

All non study specific controlled documents are also subject to periodic review. This process is managed by the document controller who maintains a list of documents and their review periods.

When a document is due for review, the document controller releases a new editable draft copy to the reviewer, who updates the text as required and returns the document to the document controller to manage the approval and issue process.

7 access, Security, storage and archiving

1 Access

Only current versions of documents should be available to document users. These individuals may be designated as having read only access. The current version must not be available to users in an editable format (pdf. copies are commonly used).

At CTU name, documents are accessed from the following locations:

• List types of documents and how each is accessed

Note: Procedures are required to be accessible at the point of use, therefore the local SOP should record how this is achieved (this may be by having access to documents on a networked PC or via quality management software or may be that a controlled hard copy is made available at the point of use).

2 Security and storage

CTUs should describe here where different documents are stored, including both hard and electronic copies. The text should include security measures to restrict access and also measures taken to ensure the integrity of the documents are maintained.

Security measures should include:

• Protection from editing (e.g. pdf. copies, read only word copies)

• Back up of electronic copies

• Password protection at network, folder or document level

• Facilities for storage of paper copies (e.g. archiving environment to protect from moisture/fire)

• Mobile storage policy

• Security of databases

3 Archiving/Retention

Previous versions should be marked as superseded and be securely archived. They must not be accessible to users except to trial management and the document controller. See also SOP Archiving.

Record here how previous versions of documents are stored, listed and accessed. This must include all formats and may also include the requirement to destroy all copies except one.

With regard to trial specific documentation/paperwork, one hard copy of all final versions of a document should be retained until after the completion of the study. The retention time and archiving method will be included in the study protocol and departmental archiving procedures.

Retaining superseded and obsolete documents as electronic copies only (i.e. not retaining a hard copy) should only be performed if a fully validated process has been established to ensure that the electronic version accurately reflects the hard copy and that there is no increased risk of loss of access or ability to view the document by not retaining a hard copy.

SUPPORTING DOCUMENTS

Where internal SOPs and other documents, e.g. template documents or work instructions, are referenced in the text, the numbers and titles are listed under this section.

|Number |Title |

| |SOP template |

| |Training SOP |

| |Archiving SOP |

| | |

references

1. CPMP/ICH/135/95: Guideline for Good Clinical Practice ICH E6 (R1)



aPPENDICES

1. Document Control Flow Chart

Appendix 1 Document Control Flow Chart

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Appropriate person to act as author Identified

Identify need for an SOP

Need for new document identified or existing document becomes due for review

Document issued for use. Copies distributed and master copy retained. Staff trained/updated

Document authorised for use by designated approvers

Forwarded to document controllerfor final compliance check and coding prior to publication

Process will repeat until Final Version agreed

Peer Review by appropriate Senior Staff member

Author/Reviewer produces draft

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