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drgopal ☆ India, 2007-08-25 10:18 (6081 d 02:02 ago) Posting: # 1016 Views: 5,599 |
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Dear all Who should fill the volunteer registration form-Clinical staff or the volunteer himself? Should the form be filled in the local regional language if the volunteer has to understand what is filled in the form or is it not necessary/requirement? Thanking you, drgopal |
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Ohlbe ★★★ France, 2007-08-27 02:33 (6079 d 09:47 ago) @ drgopal Posting: # 1022 Views: 4,448 |
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Dear drgopal, ❝ Who should fill the volunteer registration form-Clinical staff or the volunteer himself? Both can be used. But if a questionnaire (filled-in by the volunteer) is used IMHO you should also use a form completed by your staff, to confirm information from the subject from questionning and to record additional information (more complex questions, which the subject may not be able to answer directly, or recording of data such as height and bodyweight which will be measured by your staff). ❝ Should the form be filled in the local regional language if the volunteer has to understand what is filled in the form or is it not necessary/requirement? In the case of a questionnaire filled in by the subject you should use whichever language is understandable to him  ... Regards Ohlbe |
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drgopal ☆ India, 2007-08-27 13:35 (6078 d 22:45 ago) @ Ohlbe Posting: # 1028 Views: 4,532 |
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Dear Ohlbe, My question was, is it mandatory that the volunteer registration form should be filled by the volunteer in the language he understands? Or the research associate can fill the form in english evenif the volunteer doesnt understand it? Whether the form has to be filled up by both or only by research associate is sufficient? What is the regulatory requirement? Regards drgopal |
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Ohlbe ★★★ France, 2007-08-27 14:21 (6078 d 21:59 ago) @ drgopal Posting: # 1030 Views: 4,522 |
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Dear drgopal, As far as I know there is no specific regulatory requirement. If the form is filled in by the subject himself it should be completed in the language he is more comfortable with - English or vernacular. If the form is filled in by your staff, and the subject is not required to sign it, it can be completed in English. IMHO it is not mandatory for the form to be filled in by the subject himself. Regards Ohlbe |
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Charl ● 2007-08-29 11:13 (6077 d 01:08 ago) @ drgopal Posting: # 1037 Views: 4,438 |
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❝ Who should fill the volunteer registration form-Clinical staff or the volunteer himself? Should the form be filled in the local regional language if the volunteer has to understand what is filled in the form or is it not necessary/requirement? There are two major forms to be filled and understood. 1- Informed consent form. 2- Case report form. both I suggest is to be controlled by the clinical staff, to facilitate the work after words, and to be in consestent for all study reports. thus ICF should be written in the language that is most understandable by the participant, your staff should give the max. contribution to read and explain each and every point mentioned so the participant shouldnt mis-understand any point afterwords. regards... |
Ing. Helmut Schütz