Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 73
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::printArticle() - APP/Controller/ArtileDetailController.php, line 73
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Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 74
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::printArticle() - APP/Controller/ArtileDetailController.php, line 74
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 88
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Warning (512): Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853 [CORE/src/Http/ResponseEmitter.php, line 48]
Code Context
            if (Configure::read('debug')) {

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-The Economic Times&lt;br /&gt;
&lt;br /&gt;
Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.&lt;br /&gt;
&lt;br /&gt;
The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.&lt;br /&gt;
&lt;br /&gt;
A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).&lt;br /&gt;
&lt;br /&gt;
Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO).&lt;br /&gt;
&lt;br /&gt;
&amp;quot;The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?&amp;quot; said a Indian Society of Clinical Research spokesperson.&lt;br /&gt;
&lt;br /&gt;
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&lt;br /&gt;
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&lt;br /&gt;
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Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.&lt;br /&gt;
&lt;br /&gt;
The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.&lt;br /&gt;
&lt;br /&gt;
A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).&lt;br /&gt;
&lt;br /&gt;
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&lt;br /&gt;
&amp;quot;The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?&amp;quot; said a Indian Society of Clinical Research spokesperson.&lt;br /&gt;
&lt;br /&gt;
The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours.&lt;br /&gt;
&lt;br /&gt;
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&lt;br /&gt;
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Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent..."/>
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                <strong>Pharma companies to compensate for clinical trial death, injury</strong></h1>
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                <div align="justify">-The Economic Times<br /><br />Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.<br /><br />The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.<br /><br />A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).<br /><br />Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO).<br /><br />&quot;The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?&quot; said a Indian Society of Clinical Research spokesperson.<br /><br />The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours.<br /><br />The pharma company and the CRO would have to submit a detailed report on the adverse event to the ethics committee within 10 days. This report would also be sent to the independent expert committee in the DCGI in cases of death.<br /><br />The ethics committee would communicate its opinion on compensation to the independent expert committee within 21 days of the adverse event. The expert panel, after examining the merits of the case, would recommend the possible quantum of financial compensation to the drug regulator within 30 days of receiving the ethics committee report. <br /></div>               </font>
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</span></span></code>
<span class="code-highlight"><code><span style="color: #000000">&nbsp;&nbsp;&nbsp;&nbsp;&lt;link&nbsp;rel="canonical"&nbsp;href="<span style="color: #0000BB">&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">Configure</span><span style="color: #007700">::</span><span style="color: #0000BB">read</span><span style="color: #007700">(</span><span style="color: #DD0000">'SITE_URL'</span><span style="color: #007700">);&nbsp;</span><span style="color: #0000BB">?&gt;&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$urlPrefix</span><span style="color: #007700">;</span><span style="color: #0000BB">?&gt;&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">category</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">slug</span><span style="color: #007700">;&nbsp;</span><span style="color: #0000BB">?&gt;</span>/<span style="color: #0000BB">&lt;?php&nbsp;</span><span style="color: #007700">echo&nbsp;</span><span style="color: #0000BB">$article_current</span><span style="color: #007700">-&gt;</span><span style="color: #0000BB">seo_url</span><span style="color: #007700">;&nbsp;</span><span style="color: #0000BB">?&gt;</span>.html"/&gt;
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-The Economic Times&lt;br /&gt;
&lt;br /&gt;
Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.&lt;br /&gt;
&lt;br /&gt;
The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.&lt;br /&gt;
&lt;br /&gt;
A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).&lt;br /&gt;
&lt;br /&gt;
Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO).&lt;br /&gt;
&lt;br /&gt;
&amp;quot;The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?&amp;quot; said a Indian Society of Clinical Research spokesperson.&lt;br /&gt;
&lt;br /&gt;
The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours.&lt;br /&gt;
&lt;br /&gt;
The pharma company and the CRO would have to submit a detailed report on the adverse event to the ethics committee within 10 days. This report would also be sent to the independent expert committee in the DCGI in cases of death.&lt;br /&gt;
&lt;br /&gt;
The ethics committee would communicate its opinion on compensation to the independent expert committee within 21 days of the adverse event. The expert panel, after examining the merits of the case, would recommend the possible quantum of financial compensation to the drug regulator within 30 days of receiving the ethics committee report. &lt;br /&gt;
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Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.&lt;br /&gt;
&lt;br /&gt;
The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.&lt;br /&gt;
&lt;br /&gt;
A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).&lt;br /&gt;
&lt;br /&gt;
Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO).&lt;br /&gt;
&lt;br /&gt;
&amp;quot;The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?&amp;quot; said a Indian Society of Clinical Research spokesperson.&lt;br /&gt;
&lt;br /&gt;
The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours.&lt;br /&gt;
&lt;br /&gt;
The pharma company and the CRO would have to submit a detailed report on the adverse event to the ethics committee within 10 days. This report would also be sent to the independent expert committee in the DCGI in cases of death.&lt;br /&gt;
&lt;br /&gt;
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Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
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-The Economic Times

Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent..."/>
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                <strong>Pharma companies to compensate for clinical trial death, injury</strong></h1>
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                <div align="justify">-The Economic Times<br /><br />Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.<br /><br />The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.<br /><br />A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).<br /><br />Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO).<br /><br />&quot;The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?&quot; said a Indian Society of Clinical Research spokesperson.<br /><br />The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours.<br /><br />The pharma company and the CRO would have to submit a detailed report on the adverse event to the ethics committee within 10 days. This report would also be sent to the independent expert committee in the DCGI in cases of death.<br /><br />The ethics committee would communicate its opinion on compensation to the independent expert committee within 21 days of the adverse event. The expert panel, after examining the merits of the case, would recommend the possible quantum of financial compensation to the drug regulator within 30 days of receiving the ethics committee report. <br /></div>               </font>
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-The Economic Times&lt;br /&gt;
&lt;br /&gt;
Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.&lt;br /&gt;
&lt;br /&gt;
The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.&lt;br /&gt;
&lt;br /&gt;
A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).&lt;br /&gt;
&lt;br /&gt;
Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO).&lt;br /&gt;
&lt;br /&gt;
&amp;quot;The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?&amp;quot; said a Indian Society of Clinical Research spokesperson.&lt;br /&gt;
&lt;br /&gt;
The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours.&lt;br /&gt;
&lt;br /&gt;
The pharma company and the CRO would have to submit a detailed report on the adverse event to the ethics committee within 10 days. This report would also be sent to the independent expert committee in the DCGI in cases of death.&lt;br /&gt;
&lt;br /&gt;
The ethics committee would communicate its opinion on compensation to the independent expert committee within 21 days of the adverse event. The expert panel, after examining the merits of the case, would recommend the possible quantum of financial compensation to the drug regulator within 30 days of receiving the ethics committee report. &lt;br /&gt;
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Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.&lt;br /&gt;
&lt;br /&gt;
The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.&lt;br /&gt;
&lt;br /&gt;
A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).&lt;br /&gt;
&lt;br /&gt;
Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO).&lt;br /&gt;
&lt;br /&gt;
&amp;quot;The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?&amp;quot; said a Indian Society of Clinical Research spokesperson.&lt;br /&gt;
&lt;br /&gt;
The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours.&lt;br /&gt;
&lt;br /&gt;
The pharma company and the CRO would have to submit a detailed report on the adverse event to the ethics committee within 10 days. This report would also be sent to the independent expert committee in the DCGI in cases of death.&lt;br /&gt;
&lt;br /&gt;
The ethics committee would communicate its opinion on compensation to the independent expert committee within 21 days of the adverse event. The expert panel, after examining the merits of the case, would recommend the possible quantum of financial compensation to the drug regulator within 30 days of receiving the ethics committee report. &lt;br /&gt;
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-The Economic Times

Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent..."/>
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                <strong>Pharma companies to compensate for clinical trial death, injury</strong></h1>
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                <div align="justify">-The Economic Times<br /><br />Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.<br /><br />The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.<br /><br />A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).<br /><br />Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO).<br /><br />&quot;The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?&quot; said a Indian Society of Clinical Research spokesperson.<br /><br />The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours.<br /><br />The pharma company and the CRO would have to submit a detailed report on the adverse event to the ethics committee within 10 days. This report would also be sent to the independent expert committee in the DCGI in cases of death.<br /><br />The ethics committee would communicate its opinion on compensation to the independent expert committee within 21 days of the adverse event. The expert panel, after examining the merits of the case, would recommend the possible quantum of financial compensation to the drug regulator within 30 days of receiving the ethics committee report. <br /></div>               </font>
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-The Economic Times<br />
<br />
Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.<br />
<br />
The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.<br />
<br />
A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).<br />
<br />
Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO).<br />
<br />
&quot;The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?&quot; said a Indian Society of Clinical Research spokesperson.<br />
<br />
The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours.<br />
<br />
The pharma company and the CRO would have to submit a detailed report on the adverse event to the ethics committee within 10 days. This report would also be sent to the independent expert committee in the DCGI in cases of death.<br />
<br />
The ethics committee would communicate its opinion on compensation to the independent expert committee within 21 days of the adverse event. The expert panel, after examining the merits of the case, would recommend the possible quantum of financial compensation to the drug regulator within 30 days of receiving the ethics committee report. <br />
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-The Economic Times

Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent...',
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-The Economic Times<br />
<br />
Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.<br />
<br />
The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.<br />
<br />
A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).<br />
<br />
Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO).<br />
<br />
&quot;The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?&quot; said a Indian Society of Clinical Research spokesperson.<br />
<br />
The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours.<br />
<br />
The pharma company and the CRO would have to submit a detailed report on the adverse event to the ethics committee within 10 days. This report would also be sent to the independent expert committee in the DCGI in cases of death.<br />
<br />
The ethics committee would communicate its opinion on compensation to the independent expert committee within 21 days of the adverse event. The expert panel, after examining the merits of the case, would recommend the possible quantum of financial compensation to the drug regulator within 30 days of receiving the ethics committee report. <br />
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Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent...'
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Pharma companies to compensate for clinical trial death, injury

-The Economic Times Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban. The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials. A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI). Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO). "The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?" said a Indian Society of Clinical Research spokesperson. The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours. The pharma company and the CRO would have to submit a detailed report on the adverse event to the ethics committee within 10 days. This report would also be sent to the independent expert committee in the DCGI in cases of death. The ethics committee would communicate its opinion on compensation to the independent expert committee within 21 days of the adverse event. The expert panel, after examining the merits of the case, would recommend the possible quantum of financial compensation to the drug regulator within 30 days of receiving the ethics committee report.