The client then approves the recruited patients and sends the translated files ready for testing by the provider. The provider contacts the recruited patients and arranges dates for the interviews, which take place at a convenient day and time for the participants. Prior to the interview, the participant fills in a Declaration of Confidentiality and Non-Disclosure of Personal Data, as well as the clinical questionnaire itself. During the interview, the interviewer asks questions about whether the text is clear and easy to understand, whether it corresponds to the patient’s condition, how he can express the sentence in his own words and whether the questions and answers correspond to what has been said. (In the previous articles we have described in more detail the purpose and manner of the interviews). After the interview, the provider prepares and submits the following documents to the client:
- Completed questionnaire from each interview (to be filled in by the patient);
- Declaration of confidentiality and non-disclosure of personal data (to be filled in by the patient);
- Completed cognitive debriefing form for each interview (to be filled in by the interviewer);
- A report on the recruited patients (although incomplete, it is submitted before the start of the interviews so that the client can approve the participants). At the end of the project, the provider submits the same report in its final version;
- Analysis of the results (the interviewer writes down the patient’s remarks and makes suggestions for improvements in the translation);
- Audio recording of the interview (the patient is informed in advance that what he/she says will be recorded on audio media);
- Conciliation report (it includes recording the patient’s remarks, the interviewer’s opinion regarding the patient’s remarks and suggestions and making improvements in the direct and reverse translation);
- Updated translation of the clinical questionnaire in the target file.
Personal data is stored in a manner that ensures confidentiality, protection against loss, theft or destruction.
In case it is necessary to use property belonging to external providers, the conditions for its management are determined in the contract/order for assignment of the implementation of the process.
In cases where the property of a client or an external provider has been lost, damaged or otherwise found to be unusable, the manager shall inform the client or the external provider and store documented information about the incident.
We tried to present some of the basic points in cognitive debriefing and will be happy to provide you with more details if needed.
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