Guides
Guides
TJUHBB

Administration of Standard Operating Procedures

Standard Operating Procedure (SOP 01.005.3)

Suggest Edits

PURPOSE

Standard Operating Procedures (SOPs) are detailed written descriptions of how to execute a particular procedure or method. SOPs are based on national and international guidelines and conventions as well as policies and procedures that are considered “best practice” for the Thomas Jefferson University member biobanks.

The purpose of having documented SOPs is to:

  • Provide written guidelines for aspects of the TJUH tumor biobank program.
  • Promote quality and consistency in tumor biobanking and data collection across the TJUH member biobanks.
  • Ensure compliance with applicable regulations and guidelines.
  • Facilitate education and training of biobank personnel.

SCOPE

This Standard Operating Procedure (SOP) describes the processes for the development, review, approval and maintenance of all TJUHBB written SOPs. It applies to all tumor biobank personnel involved in writing, revising, reviewing, approving and maintaining SOPs.

❗️

Proficiency Testing

It is a requirement that all biorepository personnel have read all policies and procedures. Supervisors will test personnel on proficiency with the policies and submit a sign-off upon passing. Failure to pass will result in retraining on all policies and procedures.

REFERENCE TO OTHER TJUHBB SOPS OR POLICIES

  • TJUHBB POL 01.001 Quality Management Plan
  • TJUHBB POL 03.002 Director Responsibilites and Qualifications
  • TJUHBB POL 03.004 Personnel Training and Records

ROLES AND RESPONSIBILITIES

This SOP applies to all qualified tumor biobank personnel and clinical staff at the collection centers that are involved in handling participant complaints. This may include the following personnel:

Tumor Biobank PersonnelResponsibility
Laboratory Technician/Technologist Assistant/Clinical personnelWriting, Revising and updating technical SOPs
Tumor Biobank ManagerWriting, revising and updating organizational and administrative SOPs

MATERIALS, EQUIPMENT AND FORMS

The materials, equipment and forms listed in the following list are recommendations only and may be substituted by alternative/equivalent products more suitable for the site-specific task or procedure.

Materials & EquipmentSite Specific Materials
SOP Template

DEFINITIONS

See the TJUHBB Glossary.

PROCEDURES

SOPs are controlled documents designed to give instructions for performing routine and essential processes, to ensure that they are performed consistently and in a manner upholding TJUH program quality and integrity.

Developing New SOPs or Revising Previously Issued SOPs

  • TJUHBB management at the biobank or biobank personnel can identify the need for new/revised SOPs. The need can arise from the findings of a routine SOP review or from changes to regulations, guidelines, research practice, or institutional policies.
  • Individuals well versed with the procedures or methods being described should be recruited to draft or assist in drafting a new or revised SOP.
  • The SOP should follow the standard format (SOP Template); the word “draft” should be added to the header. For major revisions to previous SOPs, the major SOP version number must be incremented by one number (e.g. 01.001 becomes 01.002). For minor revisions to previous SOPs, the minor version number must be incremented by one number (e.g. 01.001 becomes 01.001.1). The first version of an SOP is always 1.
  • Develop/revise associated attachments, as applicable and revise the version date.
  • Update the SOP index as necessary (e.g., for new SOPs added or discontinued SOPs).

Review and Approval of SOPs

  • Circulate the draft SOP to the applicable reviewers (SOP working committee, management at local biobanks, biobank personnel, and other identified staff representatives – e.g., SOP users) for comments.
  • Incorporate the comments, revise the draft version date and circulate the revised draft SOP to the biobank Director or designate.
  • Review the final draft SOP for accuracy and completeness and for compliance with regulations, guidelines and standard practice. In some circumstances, this may involve IRB approval of amendment. Also, should note whether change in SOP will require amendment to other administrative documents, especially any applicable Privacy Impact Assessments.
  • Obtain approval (from a SOP authorized signatory) of the final SOP.
  • Add the effective date to the front page (the date that the final signed-off SOP is scheduled to be implemented).

Format and Content of SOPs

  • Write the SOP using the formatting and styles (e.g. Arial) as shown in the standard SOP Template.
  • Complete the heading and footer information as shown in the SOP Template.
  • The effective date refers to the date that the approved SOP is to be implemented.
  • An SOP index should be created to list all of the approved SOPs, separating them into logical categories. The example below separates the SOPs into categories corresponding to the general flow of the Tumor Biobank operations. Combining the abbreviated SOP category with the series number creates the SOP number. The original list of SOPs may contain gaps in the numbering sequence, in order to accommodate new SOPs in logical order.
SOP CategoryCategory(xx).SOP-Number (xxx).SOP-Version(x)
General Institutional Requirements of a Biobank01.001
Administration02.001
Participant Recruitment and Management
- Informed Consent		03.001
03.002
Records Management and Documentation04.001.1
  • For new SOPs, assign the next consecutive number in the appropriate category.
  • Divide the content into sections.
  • For revisions to previously issued SOPs, include a summary of and rationale for the revision at the end of each revised policy.
  • Although SOP attachments may be reviewed, revised and approved separately from the SOP, they should be stored with the applicable SOP.
  • The SOP index may also contain sub-categories if necessary.

SOP Maintenance

  • Institute a review process for SOPs.
  • SOPs should be reviewed every 2 years. The SOPs should be reviewed sooner if there are changes to regulations, guidelines, research practice, or institutional policies.
  • Once an SOP is reviewed, update the SOP index and file a copy with the Biorepository Manager.
  • If revisions to an SOP are required, follow the review and approval process of SOPs described above.
  • If only revisions to an attachment are needed, modifications may be made without revising the SOP. Revise the attachment, update the version date, and file a copy with Biorepository Manager

SOP Distribution and Communication

  • SOPs should be readily available to all tumor biobank personnel and other identified staff users.
  • Notify all biobank personnel, management members of the biobank, and other identified staff users of any new or revised SOPs, and the rationale for the SOP or SOP changes. Ideally, direct users should be notified immediately of new/revised SOPs.
  • Provide training on new or revised SOPs. Document training as appropriate to meet regional or institutional requirements.
  • Retrieve outdated copies of SOPs and attachments and replace with updated versions.
  • Outdated SOPs, appendices and SOP indices should be archived.

SOP Storage

  • The Biorepository Manager should create and maintain a central SOP file.
  • Store the following documents in the central SOP files:
    • Final, approved original and revised versions of each SOP.
    • One copy of the original and revised versions of each SOP.
    • Original, signed SOP Review Records.
    • Copies of SOP training records from the collection sites (if maintained)
  • For electronic SOPs, final SOPs should be posted in a format that cannot be altered (e.g., .pdf format). Ensure that the electronic files are checked regularly and only current SOPs are referenced.

SOP Style

  • Describe each operation in a procedure as a separate step. Make instructions explicit enough so that a qualified individual could perform the procedure by following the instructions. Make instructions explicit enough so that the SOP may be used as a training tool, and easily referred to for guidance during routine work.
  • Use clear, concise, unambiguous instructions so that the user can understand the requirements. Do not use qualifiers and vague terms such as “usually”, “sometimes”, “normally”, “regularly” or “try to”.
  • Flow charts may be included, as they are an excellent way of communicating the sequential steps of a process. Equipment diagrams and scanned images can also help personnel understand machinery, and are useful aids during hands-on training sessions.

APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES

Updated less than a minute ago