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  • Letters (digital and hard copy)  
  • Emails  
  • Standards 
  • Standards 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)

...

Documents will have an explicit name, retention category, and confidentiality.

Name - todoCategory - todo- The name of the document will be different according to the kind. 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 Category -Retention category is for how long documents stay o

Confidentiality - In order to maintain confidentiality, documents will be designated using one of five classifications:

  • Public - Available to be viewed by anybody in the world.  All documents should have a designation but any document without a designation will be considered Public.
  • Members - Available to be viewed by CDISC membership.
  • Internal - Available to be viewed by anybody within CDISC (employees and contractors). 
  • Confidential - Available to only a restricted group of CDISC employees and/or contractors. 
  • Classified - Available to only a restricted group of CDISC employees.  The Department head has to approve sharing with anyone else.  

Distribute

todo 

A document is available for employees and/or the general public according to the confidentiality classification.

Use

After the document is created, it will be available on the CDISC system, and according to its kind, it will be stored and/or distributed

  • Outlook - Internal and external Emails must be distributed through official company Email.
  • Confluence Wiki - ???
  • SharePoint / OneDrive - ???
  • Azure DevOps Wiki - Documents related to projects worked on Azure DevOps. Each Document needs to be stored within the project that it is related to.
  • GitHub Wiki - ???

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)

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

Document retention category 

...

  • When there are names of employees addressing a position within the company, specific project, or similar, the names need to be updated to the employee or contractor holding those positions. 
  • All processes and work instructions must be check to make sure that they are updated and hadn´t chance. Any small step in the process or work instruction that is different from the document to real-life needs to be updated. 


Document management 

  • Documents must include name, date of creation, version, date of the last update (if applicable), date of next review, and name of the employee or contractor in charge of the document. 
  • The employee or contractor who created the document will own it and must make sure that is review every year to check if there are updates that need to be made. 
  • When an employee leaves the company, all the documents that he or she owns will be reviewed to make sure that they are still needed. The documents that are still needed for the company will be assigned to a new employee, who from this moment, is taking responsibility for the new documents. Documents that are not needed anymore will be transferred to a file until a retention period is reached. 
  • Documents can’t have a copy in a different location. 
  • If there are two or more duplicate documents and one is an update of the previous ones, the most recent update is the want that will stay on file, and the others, after a revision, will go to the Retention Period. 
  • owner
  • last modified
  • Next review
  • status


Dispose 

Before any document could be disposed, it needs to be sent to a Retention Period where the document will follow some steps before is deleted.

Archived Period 

Documents will stay in Retention Archived Period for one year to make sure they are not needed again. After one year in Retention year in Archived Period, the head of the department, for which the document is used will take another look at the document and decide if it is time to delete the document or give a one-year extension.  

Any document that hadn´t been deleted after the first year in Retention 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 Period. 

Any document can´t stay in Retention 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 period
  • If the document is no longer required marks it as archived
  • If 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 Retention 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 Retention Archived Period. 
  • Decides if a document needs to be deleted or reestablish to its previous location after 2 years in the Retention Period. 

Document management 

  • Documents must include name, date of creation, version, date of the last update (if applicable), and name of the employee or contractor in charge of the document. 
  • The employee or contractor who created the document will own it and must make sure that is review every year to check if there are updates that need to be make. 
  • When an employee leaves the company, all the documents that he or she owns will be reviewed to make sure that they are still needed. The documents that are still needed for the company will be assigned to a new employee, who from this moment, is taking responsibility for the new documents. Documents that are not needed anymore will be transferred to a file until a retention period is reached. 
  • Documents can’t have a copy in a different location. 
  • If there are two or more duplicate documents and one is an update of the previous ones, the most recent update is the want that will stay on file, and the others, after a revision, will go to the Retention Period. 
  • owner
  • last modified
  • Next review
  • status
  • Archived Period.