...
- Letters (digital and hard copy)
- Emails
- Standards Standard Operating Procedures
- Work Instructions
- Policies and guidance
- Meeting papers and minutes
- Education material
- Reports
- Contracts
- Presentations
- Official communications
- Photographs
- Audio recordings (other than voicemail messages)
...
| Stage | Description |
|---|---|
| Create | A document needs to be well designed from the point of creation using the name, category, confidentiality classification. |
| Distribute | A document is available for employees and/or the general public according to the confidentiality classification. |
| Use | A document has been distributed internally, and can generate business decisions, further actions, or serve other purposes. (external use is outside the scope of this policy) |
| Maintain | While a document is in active use, it is necessary that the content is maintained, accurate and available. If changes in the document need to be donemade, those changes need to be documented within the document. |
| Dispose / Archive Archive | This will occur with when a document that is accessed less frequently or has reached its assigned retention periods. During this stage, the document could be destructed or transfer to a file until a retention period is reached. is no longer required. (Currently, disposal of documents is not addressed) |
Create
Only CDISC systems and licensed applications will be used to create and/or store and/or distribute CDISC documents:
...
Name - The name of the document will be different according to the kindtype. Here are some examples:
- Emails - Internal Emails can just have the title of the subject. External Emails need to have "CDISC" + title
SOPs - SOPs will include numbers at the end of the title according to the Standard, for example, 001, 002
- Work Instructions - Name of the work instruction + "Work Instructions"
- Policies and guidance - Name of the policy + "Policy" + Version
- Meeting papers and minutes - Department + "Meeting" + date
- Education material - Name of the topic + Version
- Reports - Name of the report + Department
- Contracts - Name of the employee or contractor + "Contract" + "Confidential"
- Presentations - Name of the presentation + Department
Retention Stability Category - Retention category is for how long documents stay on CDISC systemStability Category refers to the reliability of a document and if it will need ongoing maintenance.
- Class A - This kind of
...
- document will be kept without any
...
- modification since it was created for an event in the past. Examples of these
...
- documents are meeting papers and minutes.
- Class B - This kind of informational document will have a Stability Period. When the stability period is exhausted, the document will
...
- need to be reviewed by the owner
...
- to decide if the document is reliable or if it needs
...
- an update.
Confidentiality - In order to maintain confidentiality, documents will be designated using one of five classifications:
...
The document will be used meanwhile is active on the CDISC system, and for this purpose, it will be updated and maintain according to the next part of the Lifecycle. Documents need to be stored on the CDISC System to consider them official for the purpose of this policy.
Maintain
...
According to the time documents must be preserved, they will be categorized under any of the following categories:
Document revision
Each document must go through a revision to be sure that the document is updated and/or on use. The employee or contractor owner of the document is responsible for this revision.
...
- It is used for a process
- It is giving business value to the company
- It is used to back up another document.
- It was created to use in the near future.
- It was created for a project that hasn´t kicked off.
All documents considered not needed must go through a Retention Period before they are deleted. that are no longer required will be archived.
Document Update
When updating a document, the employee or contractor owner of the document needs to make sure of the following points:
...
Before any document could be disposed, it needs to be sent to a Retention an Archived Period where the document will follow some steps before is deleted.
...
Any document that hadn´t been deleted after the first year in Archived Period will be revised again after one more year for the head of the department, for which the document is used and decided if it needs to be deleted or needs to be reestablished to its previous location before Retention Archived Period.
Any document can´t stay in Archived period for more than two years to avoid using this location as a Recycle bin or a second location for documents that employees or contractors don´t want to take care of.
...
- Ensures document is revised whenever a change is required
- At end of the Stability Period, ensures that the document is fit for purpose for another periodperiod
- If the document is no longer required marks it as archivedIf the document is auto-archived by the system due to no updates at end of the retention period, reviews the archive report to ensure
- Sends documents to Archived Period when he/she considers necessary.
- Decides if a document needs to be deleted or stay one more year after the year in the Archived Period.
- Decides if a document needs to be deleted or reestablish to its previous location after 2 years in the Archived Period.