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PAASPort Process Description

 

During the initial contact phase (1) (via phone, skype or in person) we define the project scope, specify areas where PAASP should look into and set up confidentiality agreements (if necessary).

Prior to the on-site assessment, you receive information material (2), which guides you through the PAASPort procedure (incl. our visit) for an uncomplicated, fast and complete evaluation of your research operations.

You are also provided with a list of information (3) that we request from you in advance of the visit, which usually includes:

  • Current organigram and floor plan
  • Internal guidelines, SOPs, recommendations or other documentation regulating research practice
  • Catalog of in vivo/in vitro research methods used
  • Information about training programs related to research practice
  • Information about internal Compliance and Risk Management program
  • Information about internal standards for experimental data storage and handling

In addition, we ask you to complete a self-assessment form (4) that serves to give PAA

SP a first impression of your institution’s working procedures and workflows and helps to identify areas that may need additional attention.

After this information is collected, an on-site visit (5) is conducted usually by two experts from PAASP. Terms and conditions for this visit are negotiated in advance and this includes a discussion with members of the institution’s management team and research staff that are expected to be present during the visit.

The visit normally begins with a short overview by PAASP about the PAASPort program and relevant pre-agreed objectives. A dialog with your management team regarding current quality practices is then followed by face-to-face discussions with staff members and lab associates. The in-depth analysis based on the PAASPort program questionnaire is focusing on different categories, depending on the client’s needs - for example:

  • Study design of critical studies and statistical analysis
  • Data handling and storage
  • Validation of crucial research tools
  • Personnel, including training and education
  • Publications

The visit is concluded with an exit statement / presentation by PAASP summarizing the first preliminary impressions and potential next steps.

Within two weeks after the on-site visit, the Evaluation Report (6) is written based on all accumulated information. We construct an assessment outcome profile that provides information in terms of absolute performance indicators as well as relative risk of producing biased research products. Relative risk of biased research is expressed using PAASP’s proprietary scale system.

Writing of a PAASPort Report is an interactive procedure between us and the management team; therefore, constant contact and information exchange are maintained. In collaboration with the client, we develop solutions (7) for detected problems and issues and aim to trigger and guide contin

uous quality improvement steps including training and educational programs.

Finally, dependent on the service provided and, if appropriate, the evaluation outcome, the PAASPort Quality Label (8) and/or Training Certificates (9) are awarded and remain valid for 3 years and the complete process can be finished in3-4 weeks (see scheme), including an on-site visit by our experts.

 

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