Getting your data

1. Electronic CRF Design

Templates

• ODK.
• Provide links to ODK templates
• Teleform.
• Provide links to teleform templates

Examples

• eCRF sectioning.
• Question numbering.
• Variable naming.
• Question options.

Conventions

• Teleform - sample questionnaires with peermission from study PIs.
• ODK - sample questionnaires with peermission from study PIs.
• Variable naming.
• Question options.

• Data Extracts (STATA)
• Stata data extracts consist of a set of do files that are run by the study team to extract and label their data accordingly.
• LIMS Self Service Reports
• LIMS self service reports are a convenient way for study teams and researchers, as well as the data team, to query and extract Lab results using a simple front end. Results can be extracted by organism, by project, by age group and by specified time period.

The archive is an official memory of MLW. It is set to collect, organizes, preserves and make available primary and secondary source material for research and operations.

Paper

• PROCEDURES

1. Appraisal
Records are assessed at the end of study period or financial year for possible recommendation for archiving. If you can answer yes to any of the following questions then you have a record worth archiving
• Do you need it to prove something did or did not occur?
• Do you think an auditor would require you to retain it?
• Could it be used to resolve a dispute in future?
• Does it support the business of the MLW?
• Does it have business, research, legal or historic value?
• Does it fit into the MLW’s file plan?
2. Classification
• Identify and categorize records on the basis of their subject matter and subject category, and assigned them to a file that bears a unique identity.
• Clearly label archive box with unique box number.
3. Packaging
• Each box contains records that have the same retention periods.
• Don't overfill a box, making it too heavy to carry. So, exactly how heavy is too heavy? The Health and Safety Manual gives some guidance regarding safe lifting weights.
4. Preparation of transmittal list.
5. Submit archive boxes together with dully completed and signed transmittal list to the Archivist.

• LENDING SERVICE (RETRIEVING AND RETURNING)

• Heads of Departments and Principle Investigators submit formal retrieval request to the Archivist by using the Archive Retrieval Request Form
• All returns are re-filed within 14 working days.

• RETENTION

• This is a period of time a record is kept as set by specific legislation before being disposed by physical destruction or alienation from the custody of MLW. During this period, the following exercises are conducted:
• Quarterly monitoring, auditing and inspection of the records.
• Quarterly monitoring, auditing and inspection of the facility.

• DISPOSAL

• Notification to the Principle Investigators and Heads of Departments about records expiry.
• Principle Investigators and Heads of Departments authorize destruction of those records unless they are required for known, or reasonably anticipated, litigation, inquiries or investigations or there is a demonstrable continuing business need for access to them. Retention is not based on 'just in case' the the records might be required at some time in the future.
• The Director approves the destruction of those records.
• Environmental friendly paper disposal procedures are followed.

• Data.

4. Quality Assurance & Quality Control (QA & QC)