How does your institute note deficiencies related to inspections? Inspections are an important part of regulating research, necessary for ensuring quality, safe, and acceptable conditions are maintained to aid, not detract from research goals. There are numerous reasons to audit and inspect researcher’s labs on a recurring basis, for example, hazardous agent use, MSDS binders, chemical hygiene, safety equipment, semi-annual animal housing inspections, etc. One simple way of recording and tracking audit information is to include this information on the protocol itself, or on a linked or associated master “Inspections” protocol.
As always, while the investigators /PIs should be informed of the end results of your inspections, the details of the compliance staff’s work should not be visible. There are multiple ways to restrict access to Management information; most scientific / protocol staff do not have access to any of the Management tabs in compliance protocols in Human, Animal, and Safety protocol records. While the use of UDFs may be considered, there is generally the need for lots of information to be collected and observed by multiple people.
As a best practice, three features of the Compliance modules would be recommended in this case, namely, using Administrative Submissions, Administrative documents and eForms, and eForm question security. These are each configurations of standard features, and can be used to restrict the study staff from seeing administrative information. We’ll review each one, describing their uses, and practical applications:
Administrative Submissions: Each submission (set up in Submission Types) can be marked as “Administrative”. This option causes the submission type to be hidden from the Development (Submissions) side of a protocol, so that a PI cannot see the submission type, and cannot access or create it. Eforms or documents can be added to the “Administrative Submission Type” on the eForm Sets page, or uploaded directly. These can be viewed and accessed by those with admin security. In addition, after documents are filled out/uploaded, the package can be submitted into a special route, configured to pass on to anyone needing to be informed (compliance office, facility managers, etc.). This can take advantage of existing routing and workflow paths, or you can create an inspection-specific route.
Administrative documents and eForms: In the eForm Sets configurations, eForms and document placeholders can be designated each as “Administrative”. This designates the eForm / document as being only available to administrators (with any baseline admin role or investigator with mgmt role), not to Investigators. These eForm / documents cannot be added to the submission package by Investigators (security is present on the submission Add picklist). Once added, the forms should will be visible to the PI, but the questions within can be hidden by eForm security.
Administrative eForm Questions: In each eForm question setup page, there is a lock icon next to the save icon. Clicking this icon will open a popup that allows defining the question by baseline (system) or Workflow security mapping to a role, or by a named person. Options for configurations include None (no checkboxes), Edit, or View per person or role. For instance, a choice of PI or Investigator with no check boxes and a Department Admin III row with Edit and View will allow the Department Admin III to see and modify the question’s answer, but the PI or Investigator will not be able to see either the question or the answer. There is also an “Everyone” option, whereby everyone will have the defined security, for example View, while a single person can be designated to enter an answer, such as a named person who is a Dean. In general, if a person or role is named on the security, it a rule rather than an exception.
Try out the configurations, and consider using the Administrative functions of Submissions, eForms, documents, and eForm questions in your office!
