CHECKLIST FOR SITE SOP REQUIRED ELEMENTS:
CHECKLIST FOR SITE SOP REQUIRED ELEMENTS:
Document and Record Control
|Author: Erin Gover |Document Number: |Pro71-06 |
| |Effective (or Post) Date: |7-Aug-08 |
|Review History |Date of last review: |3 April 2020 |
| |Reviewed by: |Heidi Hanes |
|pSMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific |
|processes and/or specific protocol requirements. Users are encouraged to ensure compliance with local laws and study protocol |
|policies when considering the application of this document. If you have any questions contact SMILE. |
|Element |CONTENT-SPECIFIC REQUIRED ELEMENTS |
|Present | |
|DOCUMENT CREATION AND MANAGEMENT |
| |All documents, to include policies, processes, procedures, and forms, are maintained in a controlled manner. |
| |The methods for identifying and handling the need for new documents or the need for changes to existing documents are |
|a) |described. |
| |The process for writing and approving documents is described. |
|b) |The review process (initial, annual, and as needed with changes to policies, processes, procedures, etc.) is described. |
| |Reviews are documented annually and include the laboratory director or designee’s signature. |
|c) |Documents are uniquely identified and listed on a document master list. |
| |The use of the document master list is described. |
|d) |There is a method for filing the master copy of the current version of the document and the master copies of any |
| |obsolete/retired versions of the document. This may include a document master file. |
|e) |All working copies of a document are made from the master copy of the document. Distribution and destruction of working |
|f) |copies is tracked. |
|g) |Staff is familiarized with documents, and their knowledge of document contents is documented. |
| |Staff is notified of changes to documents, and the notification is documented. |
| |Documents are retired/archived according to set procedures. A copy of the retired document is maintained. Retired documents |
| |are clearly marked to prevent inadvertent use. Retirement/archiving is noted on the document master list. |
|h) |Documents are stored in an environment that limits access to authorized personnel and maintains document integrity. Methods |
| |for labeling stored documents, location of storage, and retention times are described. |
|i) | |
| | |
|j) | |
|k) | |
| | |
| | |
|l) | |
|Comments: |
|PROCEDURE |
| |All procedures are maintained in a controlled manner. |
|a) |Procedures are written in a standardized format. |
| |Master and working copies of all procedures must be controlled. They are assigned a unique identifier and are included in a |
|b) |document/SOP master list. |
| |All procedures are reviewed and approved by the Lab Director prior to implementation. |
|c) |All staff is familiarized with the procedures as part of their training, and staff knowledge of procedures is documented. |
| |Procedures are reviewed by the Lab Director or designee at least annually for accuracy and relevance or as needed due to |
|d) |method revision, policy changes, etc. |
|e) |Review history is documented. |
| |Revisions to procedures results in changes to version number and effective date. |
|f) |All revisions should be documented in ink on the original copy along with initials of the supervisor/designee and the date of |
|g) |the change. |
|h) |Revision history is documented. |
| |Revisions are communicated to staff, and staff knowledge of changes is documented. Any additional training resulting from |
| |revision is documented. |
|i) |Retired or obsolete versions of procedures are clearly identified, archived, and removed from the general working area in |
|j) |compliance with the general document control plan. |
| |Retention times for obsolete/retired versions of procedures are established. DAIDS recommends that retired procedures are |
|k) |kept indefinitely. |
| | |
| | |
|l) | |
| |Copies of network/protocol-specific manuals, protocols, documents, and appendices are available. |
|a) | |
|Comments: |
|RECORDS |
| |All laboratory records (requisitions, patient results, QC logs, maintenance logs, QA logs, etc.) are maintained in a |
| |controlled manner. |
|a) |Records are created in standardized formats. |
|b) |Records are uniquely identified. They may be included on a records index. |
|c) |Records are reviewed regularly. Reviews are documented. |
|d) |Records are stored in an environment (on or off site) that limits access to authorized personnel and maintains document |
| |integrity. Methods for labeling stored records, location of storage, and retention times are described. |
| |Records are stored in an orderly manner that allows retrieval within 24 hours. |
|e) |There are methods for destruction of records. Destruction of records is documented. |
|f) |The need for changes to a record is identified. Relevant individuals (such as laboratory management and patient caregivers) |
|g) |are notified of the change. The change is documented. The documentation includes the original record, the modified record, |
| |the name of the individual who modified the record, the date of the modification, the name of the individual making |
| |notifications, the date of notifications, and the individuals notified. |
|Comments: |
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