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kaushik089 ★ India, 2011-12-31 08:43 (5289 d 02:03 ago) Posting: # 7833 Views: 6,397 |
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hello all, first of all i wish u all a very happy new year in advance ! As per GCP confidentiality of records that could identify subjects has to be protected but DCGI is giving approval stating some conditions like individual icf has to be given to the volunteers and also has to be video & audio recorded... is it ethical to take videos of such activities?  thanks in advance, kaushik089 |
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drgunasakaran1 ★★  2012-01-01 18:49 (5287 d 15:57 ago) @ kaushik089 Posting: # 7844 Views: 5,577 |
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Dear Mr.Kaushik, Recently, DCGI issue the following statement in the BE NOC letter for most of the submitted applications. "You should ensure that, during informed consent process, information to the subjects is provided individually and not in a group." We never encountered a statement that the ICF process need to be both audio and video captured. Even if DCGI insists to do audio and video recording, it will give additional protection to the CROs that the ICF process are given as per the GCP and ICMR guidelines. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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kaushik089 ★ India, 2012-01-02 09:39 (5287 d 01:08 ago) @ drgunasakaran1 Posting: # 7845 Views: 5,526 |
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hello sir, As u remember the recent issue happend in hyderabad CRO for recruiting illiterates & that too without obtaining there consent taken into a clinical study, unfortunately after participating one of the volunteer has lost her life @(pidugurala), to over come this fact DCGI implemented some rules to the CRO'S for practicing video capturing while presenting ICF. But this will effect the privacy of that subjects isn't it ? please give your opinion  thanks in advance, kaushik panigrahi. |
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drgunasakaran1 ★★ 2012-02-06 15:08 (5251 d 19:39 ago) @ kaushik089 Posting: # 8061 Views: 5,361 |
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Dear Mr.Kaushik, It will not affect the Privacy of the subjects since all the video tapes will be kept in the confidential archival files and will be revealed to the Regulatory authorities only if needed. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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kaushik089 ★ India, 2012-02-10 17:08 (5247 d 17:39 ago) @ drgunasakaran1 Posting: # 8102 Views: 5,302 |
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Dear dr.gunasakaran! thank u for ur valuable info but this info leads me to another doubt that as u said "all the video tapes will be kept in the confidential archival files and will be revealed to the Regulatory authorities only if needed" so is this info should also incorporated in the informed consent ? thanks in advance, kaushik089 |
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Helmut ★★★   Vienna, Austria, 2012-02-10 18:38 (5247 d 16:09 ago) @ kaushik089 Posting: # 8104 Views: 5,270 |
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Dear Kaushik! ❝ so is this info should also incorporated in the informed consent ? IMHO yes. BTW, in the future please avoid SMS-style in the forum – or are you on the run? See this post. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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drgunasakaran1 ★★ 2012-02-11 06:46 (5247 d 04:01 ago) @ kaushik089 Posting: # 8107 Views: 5,276 |
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❝ so is this info should also incorporated in the informed consent ? Dear Mr.Kaushik, Yes, the video recording details need to be informed to the subjects and the video recording information should be captured in the Informed consent document. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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akinapally ☆ 2013-11-21 12:46 (4597 d 22:01 ago) @ drgunasakaran1 Posting: # 11933 Views: 4,398 |
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hi, Is these audio and video records can be accessed to the monitor (sponor or third party) during the study visit for view or review or audit? |
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Ohlbe ★★★ France, 2014-01-10 13:49 (4547 d 20:58 ago) @ akinapally Posting: # 12154 Views: 4,299 |
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Dear all, The CDSCO has just issued draft guidelines on this topic. Comments are awaited by 16 January (only one week comments !). Edit: THX! Subject line changed. [Helmut] — Regards Ohlbe |
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drgunasakaran1 ★★ 2014-01-13 06:48 (4545 d 03:59 ago) @ Ohlbe Posting: # 12158 Views: 4,501 |
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Dear all, Some Interesting and Salient points from the guidance The process of signing/putting thumb impression by the subject/LAR/IW should also be video recorded. In order to identify the subject/LAR/IW his/her photo ID may be documented. The video camera for the audio-visual recording should be of adequate capability to simultaneously capture the facial details of subject, LAR/Impartial Witness (if any), Investigator/authorised person present during the consent process. The audio-visual recording should be conducted in a room conducive to recording of disturbance-free audio and video of the consent process. During the videography process, care should also be taken not to include unrelated persons/patients at the hospital within the field of vision. The video recording should be done using video camera of appropriate resolution and in a room free from any disturbance to ensure that the image is recognizable and the audio is clearly audible. In order to maintain the confidentiality, the videographer should be engaged as part of the study team. Prior to initiation of the study, the Investigator should define and allocate the activities of audio-video recording of informed consent process to the respective identified person as videographer. The Investigator shall maintain the details of the person to whom he has delegated the duties of audio video recording. Source: CDSCO's Draft guidelines on audio-visual recording of Informed consent process in clinical trials — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
Ing. Helmut Schütz