Rights and responsibilities in SKUP evaluations
The evaluation protocol is written by SKUP and approved by the requesting company. The evaluation is affirmed in a written contract between the requesting company and SKUP. The requesting company cannot question the accepted evaluation procedure in retrospect.
If an evaluation is delayed due to factors of which the requesting company is responsible, SKUP is not bound by the agreed upon deadline for completing the report. If the delay is considerable or leads to additional work or expenses for SKUP, economic compensation may be sought. If the requesting company has postponed an evaluation, the requesting company must notify SKUP at least three months before they are ready to resume the evaluation process.
SKUP will contact the requesting company if any technical problems with the equipment occur during the evaluation. If preliminary calculations show unexpectedly poor analytical performance, SKUP will notify the requesting company and assist in identifying the problem. The evaluation can be stopped if SKUP and the requesting company agree this is the appropriate course of action. This can be if technical problems cannot be solved, or if a disagreement between the parties cannot be resolved.
SKUP takes no responsibility for any indirect effects of results or assessments in a SKUP report, such as loss of business profit.
Raw data and report
SKUP stores the original raw data for four years. The raw data are owned by SKUP. Attachments with confidential raw data are included in the final report received by the requesting company, however, no information about individual participants will be provided. In the contract, the requesting company agrees to use raw data solely for internal purposes. Other use of the raw data, e.g., for IVDR purposes, should be approved by SKUP. The raw data included in the report to the requesting company includes sampling date, result on evaluated measuring system, result on comparison method, result on internal quality control and possible other results necessary for the interpretation of the conclusions of the report, e.g., haematocrit.
SKUP is responsible for the processing of data and writing the report. All results are confidential during the evaluation.
The report is written in English with summaries in English, Danish, Swedish and Norwegian. The report is submitted to the requesting company for initial comments with a deadline of 14 days. SKUP will consider proposed alterations and make any accepted changes. If the requesting company disagrees with SKUP’s interpretations, they may add an attachment to the report. Depending on its content, there may be a further written response from SKUP added. The requesting company’s contribution must only apply directly to the results and assessments in the report and cannot be used for marketing purposes. Results from other studies cannot be commented on or included in the attachment. The requesting company is encouraged to give detailed feedback about the evaluation process in a client contentment survey.
The requesting company must complete the processing of the report and comment within a month from the date the report was sent by SKUP. In consultation with SKUP, this period may be extended, after which SKUP will finalize the report. Raw data is not a part of the public report, unless it is required for interpretation of the results.
Publishing
If the measuring system is already marketed in Scandinavia, the report and summaries will be published on SKUPs website. SKUP summaries may be translated into Italian by Centre for Metrological Traceability in Laboratory Medicine (CIRME) and published on their website. SKUP has no responsibility for the publication of SKUP results elsewhere than www.skup.org.
The report from the evaluation may be kept confidential as long as the system is not launched in Scandinavia.
SKUP reserves the right to publish results from evaluations that are not kept confidential as described above. After permission from the SKUP Steering Committee, data from a published SKUP evaluation may also be used in research projects. In such cases, SKUP will notify the requesting company and send them a draft of the manuscript for comments at least 14 days prior to submission for publication. Should the requesting company have any comments, these must be submitted to SKUP in writing within 14 days of receipt. SKUP, however, has the final authority to determine the scope and content of any publications.
Every SKUP evaluation is allocated a unique evaluation number. If the results from the evaluation or the SKUP name is used for marketing purposes, there must be a reference to www.skup.org and the evaluation number. For this purpose, the requesting company may use a SKUP logotype containing the evaluation number, which will be made available to the requesting company with the final report. If the results from a confidential SKUP evaluation are used in marketing or publicly by the requesting company in any form, the report will be published by SKUP.
Further information about the SKUP evaluation is available at our website: About evaluations.
