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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