Annex B:@0.811356:0.070061:0.917239:0.070061:0.917239:0.049402:0.811356:0.049402:0.021235:0.014706:0.014706:0.013059:0.014706:0.007853:0.019618
Indemnity for Clinical Studies:@0.294526:0.123407:0.672291:0.123407:0.672291:0.103111:0.294526:0.103111:0.011265:0.016353:0.016353:0.012794:0.024500:0.016118:0.008176:0.009794:0.014471:0.007353:0.009794:0.014294:0.012824:0.007853:0.021235:0.008000:0.008176:0.016353:0.008176:0.012882:0.014706:0.008176:0.007765:0.016088:0.009794:0.015941:0.016176:0.008176:0.012735:0.011441
 :@0.672141:0.123407:0.679493:0.123407:0.679493:0.102747:0.672141:0.102747:0.007353
Sponsored by Pharmaceutical companies:@0.293709:0.149479:0.808033:0.149479:0.808033:0.129183:0.293709:0.129183:0.016176:0.016176:0.014529:0.016353:0.011265:0.014529:0.013059:0.012676:0.016176:0.008647:0.016353:0.015029:0.007029:0.017971:0.016176:0.014706:0.013059:0.024500:0.014706:0.013059:0.012853:0.016353:0.009794:0.008176:0.013059:0.014706:0.008176:0.008971:0.012824:0.014471:0.024029:0.016000:0.014471:0.016000:0.008000:0.012824:0.011441
Section One:@0.293709:0.190073:0.444180:0.190073:0.444180:0.169778:0.293709:0.169778:0.016088:0.013059:0.012765:0.009794:0.007941:0.014471:0.016088:0.008647:0.022471:0.016088:0.013059
1. :@0.295245:0.225139:0.309951:0.225139:0.309951:0.213662:0.295245:0.213662:0.007108:0.003513:0.004085
Clinical research involving the administration of drugs to patients or non-patient human :@0.341160:0.225139:0.918938:0.225139:0.918938:0.213662:0.341160:0.213662:0.010703:0.004542:0.004542:0.007908:0.004542:0.007059:0.007255:0.004542:0.004085:0.005605:0.007255:0.006356:0.007255:0.007484:0.005441:0.007255:0.008382:0.003513:0.004542:0.008170:0.008170:0.008170:0.004542:0.008170:0.004542:0.008170:0.008170:0.003611:0.004542:0.008170:0.007255:0.004788:0.007255:0.008170:0.012712:0.004542:0.008170:0.004542:0.006356:0.004542:0.005441:0.007255:0.004542:0.004542:0.008170:0.008170:0.003627:0.008905:0.005964:0.002778:0.008170:0.005441:0.008170:0.007958:0.006356:0.003856:0.004542:0.008170:0.004085:0.008170:0.007255:0.004379:0.004542:0.007255:0.008170:0.004542:0.006356:0.004673:0.008497:0.005637:0.003513:0.008170:0.008170:0.008333:0.005441:0.008170:0.007255:0.004706:0.004542:0.007255:0.008170:0.004542:0.004493:0.008170:0.008170:0.012712:0.007059:0.008170:0.004085
volunteers is frequently undertaken under the auspices of:@0.340016:0.243005:0.714493:0.243005:0.714493:0.231528:0.340016:0.231528:0.008170:0.008333:0.004542:0.008170:0.008170:0.004542:0.007255:0.007255:0.005441:0.006356:0.004314:0.004542:0.006356:0.004085:0.005441:0.005441:0.007059:0.008170:0.008170:0.007026:0.008170:0.004542:0.004542:0.007990:0.004330:0.008170:0.008415:0.008333:0.007255:0.005441:0.004788:0.007255:0.008431:0.007255:0.008350:0.003186:0.008170:0.008170:0.008333:0.007255:0.005654:0.003595:0.004542:0.007958:0.007255:0.004510:0.007255:0.008170:0.006356:0.007958:0.004542:0.007255:0.007075:0.006356:0.004673:0.008660:0.005441
Health Authorities or NHS Trusts.:@0.339624:0.260934:0.563873:0.260934:0.563873:0.249457:0.339624:0.249457:0.012173:0.007435:0.007435:0.004542:0.004542:0.008562:0.004085:0.011520:0.008170:0.004542:0.008170:0.008170:0.005441:0.004542:0.004542:0.004542:0.007255:0.006356:0.004085:0.008611:0.005637:0.003186:0.011601:0.011601:0.008905:0.004739:0.009641:0.005441:0.007794:0.006356:0.004183:0.006356:0.004085
2. :@0.294526:0.296667:0.309967:0.296667:0.309967:0.285189:0.294526:0.285189:0.007598:0.003758:0.004085
When the study is sponsored by a pharmaceutical company, issues of liability and :@0.340768:0.296667:0.878905:0.296667:0.878905:0.285189:0.340768:0.285189:0.015768:0.008170:0.007435:0.008170:0.003186:0.004542:0.007958:0.007255:0.005000:0.006356:0.004346:0.007925:0.007925:0.007925:0.004330:0.004542:0.006078:0.005065:0.006356:0.008170:0.008170:0.008170:0.006356:0.007958:0.005441:0.007255:0.007974:0.003186:0.008170:0.008170:0.004820:0.007435:0.003513:0.008170:0.008007:0.007255:0.005441:0.012712:0.007255:0.007255:0.007255:0.008170:0.004542:0.004542:0.007255:0.007255:0.004542:0.004265:0.007255:0.007941:0.012500:0.008170:0.007255:0.007941:0.008170:0.003922:0.005147:0.004542:0.006078:0.006356:0.007941:0.007255:0.006356:0.004608:0.008905:0.005964:0.002778:0.004542:0.004542:0.007092:0.008170:0.004330:0.004542:0.004542:0.004314:0.008170:0.004085:0.007255:0.008170:0.008170:0.004085
indemnity may arise in case of injury associated with administration of:@0.340768:0.314532:0.804706:0.314532:0.804706:0.303054:0.340768:0.303054:0.004542:0.008170:0.008170:0.006977:0.012712:0.007958:0.004542:0.004363:0.008170:0.004984:0.012255:0.006944:0.007843:0.004739:0.007255:0.005163:0.004542:0.006160:0.007255:0.004510:0.004820:0.008497:0.003595:0.007255:0.006961:0.006127:0.007255:0.004510:0.008987:0.005964:0.003105:0.004542:0.008170:0.004281:0.008007:0.005441:0.007958:0.004330:0.007255:0.006356:0.006356:0.008170:0.007255:0.004542:0.007255:0.004542:0.007255:0.008170:0.003840:0.012092:0.004542:0.004771:0.008415:0.003513:0.007255:0.008350:0.012712:0.004542:0.008170:0.004542:0.006356:0.004542:0.005441:0.007451:0.004542:0.004542:0.008170:0.008170:0.003660:0.008660:0.005441
the drug or other aspects of the conduct of the trial.:@0.340359:0.332399:0.673121:0.332399:0.673121:0.320922:0.340359:0.320922:0.004542:0.007958:0.007255:0.004592:0.008170:0.005441:0.008366:0.008170:0.004085:0.008170:0.005441:0.004085:0.008170:0.004542:0.008170:0.007255:0.005441:0.003873:0.007255:0.006356:0.008170:0.006977:0.007255:0.004542:0.006176:0.004248:0.008987:0.005964:0.002369:0.004542:0.008170:0.007255:0.004706:0.007255:0.008170:0.008170:0.008170:0.008170:0.007255:0.004542:0.004085:0.008807:0.005964:0.002369:0.004542:0.007958:0.007255:0.004085:0.004542:0.005114:0.004330:0.006944:0.004248:0.004085
3. :@0.294118:0.368194:0.309559:0.368194:0.309559:0.356717:0.294118:0.356717:0.007598:0.003758:0.004085
When the study is not sponsored by a company but has been independently organised by :@0.340359:0.368194:0.919771:0.368194:0.919771:0.356717:0.340359:0.356717:0.015605:0.008170:0.007255:0.008170:0.003203:0.004542:0.007958:0.007255:0.004918:0.006127:0.004542:0.007876:0.008007:0.008007:0.003922:0.004542:0.006356:0.004379:0.008007:0.007925:0.004542:0.004608:0.006356:0.008170:0.008170:0.008170:0.006356:0.007958:0.005441:0.007255:0.007974:0.003186:0.008170:0.008170:0.004412:0.007435:0.003922:0.007255:0.008170:0.012353:0.008170:0.007255:0.007941:0.008170:0.003431:0.008415:0.008415:0.004739:0.004330:0.007925:0.007026:0.006356:0.003448:0.008415:0.007598:0.007598:0.008497:0.003186:0.004542:0.008170:0.007958:0.007255:0.007941:0.007255:0.008170:0.008170:0.007255:0.008170:0.004542:0.004542:0.008170:0.004265:0.008170:0.005441:0.008170:0.007255:0.008170:0.004542:0.006356:0.007255:0.008170:0.003137:0.008170:0.008333:0.004085
clinicians, the NHS body will carry full legal liability for claims:@0.340359:0.386059:0.757827:0.386059:0.757827:0.374582:0.340359:0.374582:0.007255:0.004542:0.004379:0.008170:0.004248:0.007255:0.004346:0.007255:0.007859:0.006356:0.003856:0.004739:0.004542:0.007958:0.007255:0.003775:0.011797:0.011797:0.008922:0.003922:0.008333:0.008333:0.008170:0.008497:0.004330:0.011601:0.004542:0.004542:0.004542:0.004592:0.007255:0.006961:0.005441:0.005261:0.008007:0.004330:0.005441:0.008170:0.004542:0.004542:0.004085:0.004542:0.007075:0.008170:0.007255:0.004542:0.004379:0.004542:0.004542:0.007092:0.008170:0.004330:0.004542:0.004542:0.004314:0.008170:0.004248:0.005441:0.008529:0.005637:0.003922:0.007026:0.004542:0.006977:0.004542:0.012288:0.006356
in negligence arising from harm to subjects in the study.:@0.340359:0.403927:0.705719:0.403927:0.705719:0.392449:0.340359:0.392449:0.004542:0.008448:0.003513:0.008170:0.007255:0.008170:0.004346:0.004542:0.008170:0.007255:0.007974:0.007255:0.007042:0.004739:0.007255:0.005245:0.004542:0.006356:0.004542:0.008170:0.008170:0.003922:0.005441:0.005670:0.008415:0.013072:0.003513:0.008170:0.007255:0.005441:0.012876:0.003513:0.004330:0.007843:0.005474:0.006127:0.007925:0.008007:0.004542:0.006977:0.007255:0.004346:0.006356:0.004510:0.004542:0.008448:0.003105:0.004542:0.008170:0.007255:0.005114:0.006127:0.004248:0.007680:0.007680:0.007680:0.004085
4. :@0.294118:0.439722:0.309559:0.439722:0.309559:0.428245:0.294118:0.428245:0.007598:0.003758:0.004085
The guidance in Section 2 and the Appendix has three purposes::@0.340359:0.439722:0.758464:0.439722:0.758464:0.428245:0.340359:0.428245:0.009722:0.007925:0.007255:0.004510:0.008170:0.007925:0.004542:0.007958:0.007255:0.007859:0.007255:0.007255:0.004526:0.004820:0.008578:0.004248:0.009085:0.007255:0.007255:0.004346:0.004542:0.008170:0.008170:0.003382:0.007435:0.005065:0.007255:0.008170:0.008170:0.003529:0.004542:0.007958:0.007255:0.004918:0.011797:0.007974:0.008170:0.007255:0.008170:0.008170:0.004542:0.008170:0.004085:0.007810:0.007026:0.006356:0.004085:0.004542:0.008170:0.005441:0.007255:0.007255:0.004281:0.007925:0.008007:0.005441:0.007876:0.008007:0.006127:0.007255:0.006062:0.004542
• :@0.340768:0.475139:0.349183:0.475139:0.349183:0.463662:0.340768:0.463662:0.004330:0.004085
to ensure that NHS bodies enter into appropriate agreements which will provide :@0.385866:0.475139:0.911258:0.475139:0.911258:0.463662:0.385866:0.463662:0.004542:0.008170:0.004526:0.007255:0.007941:0.006356:0.007941:0.005441:0.007059:0.004330:0.004542:0.008170:0.007255:0.004542:0.003676:0.011797:0.011797:0.009085:0.003840:0.008170:0.008333:0.008170:0.004739:0.007255:0.006356:0.004771:0.007255:0.008170:0.004542:0.007484:0.005441:0.004085:0.004363:0.007761:0.004330:0.007761:0.005147:0.007255:0.008170:0.008170:0.005245:0.008170:0.008007:0.005441:0.004542:0.007010:0.004542:0.007255:0.004624:0.007255:0.008170:0.005441:0.007075:0.007255:0.012435:0.007255:0.008170:0.004346:0.006356:0.004265:0.012010:0.008333:0.004542:0.007549:0.008333:0.003105:0.011797:0.004542:0.004542:0.004542:0.004085:0.007990:0.005441:0.007958:0.008007:0.004542:0.007876:0.007255:0.004085
indemnity against claims and proceedings arising from :@0.385866:0.493004:0.748023:0.493004:0.748023:0.481527:0.385866:0.481527:0.004542:0.008170:0.007958:0.007255:0.012712:0.008170:0.004379:0.004542:0.008170:0.004690:0.007255:0.008170:0.007042:0.004542:0.008170:0.006160:0.004542:0.004363:0.007255:0.004542:0.007075:0.004542:0.012712:0.006193:0.004330:0.007435:0.008170:0.008333:0.003513:0.008170:0.005441:0.008170:0.007255:0.007255:0.007255:0.008170:0.004542:0.008170:0.008170:0.006356:0.004542:0.007255:0.005441:0.004542:0.006356:0.004542:0.008170:0.008170:0.003399:0.005441:0.005441:0.008170:0.012712:0.004085
company-sponsored clinical studies;:@0.388235:0.508155:0.625604:0.508155:0.625604:0.496678:0.388235:0.496678:0.007255:0.008170:0.012435:0.008170:0.007255:0.008170:0.008170:0.005441:0.006356:0.008170:0.008170:0.008170:0.006356:0.008170:0.005441:0.007255:0.008170:0.004085:0.007075:0.004542:0.004542:0.007990:0.004542:0.007255:0.007255:0.004542:0.004673:0.006356:0.004542:0.007974:0.008170:0.004542:0.007059:0.006356:0.004542
• :@0.341176:0.539975:0.349592:0.539975:0.349592:0.528497:0.341176:0.528497:0.004330:0.004085
to ensure that NHS bodies, where appropriate, use a standard form of agreement :@0.387827:0.539975:0.916225:0.539975:0.916225:0.528497:0.387827:0.528497:0.004330:0.007843:0.005065:0.007026:0.008007:0.006356:0.007859:0.005229:0.007255:0.004085:0.004837:0.008333:0.007255:0.004755:0.003513:0.011601:0.011797:0.008791:0.004330:0.008170:0.008170:0.008170:0.004542:0.007255:0.006356:0.004085:0.004641:0.011797:0.007974:0.007255:0.005441:0.007075:0.004739:0.007255:0.008170:0.007859:0.005441:0.007876:0.008007:0.005441:0.004542:0.007010:0.004542:0.007255:0.003889:0.004657:0.008170:0.006356:0.007042:0.004739:0.007435:0.004330:0.006356:0.004542:0.007255:0.007990:0.008170:0.007255:0.005245:0.008170:0.003431:0.005441:0.008448:0.005441:0.013186:0.003922:0.008987:0.005964:0.002696:0.007255:0.008170:0.005245:0.007255:0.007255:0.012712:0.007255:0.008170:0.004542:0.004085
(Appendix) which has been drawn up in consultation with:@0.388235:0.557904:0.766716:0.557904:0.766716:0.546427:0.388235:0.546427:0.005441:0.011634:0.008170:0.007843:0.007255:0.007941:0.008170:0.004248:0.008007:0.005441:0.004690:0.011797:0.008170:0.004788:0.007255:0.008350:0.003922:0.007925:0.007026:0.006356:0.003775:0.008497:0.007598:0.007598:0.008497:0.003513:0.008170:0.005441:0.007255:0.012059:0.008170:0.003268:0.008007:0.008007:0.004330:0.004902:0.008824:0.003513:0.007255:0.008170:0.008350:0.006356:0.008170:0.004542:0.004542:0.007435:0.004542:0.004542:0.008170:0.008170:0.003333:0.011797:0.004542:0.004542:0.008170
the Association of the British Pharmaceutical Industry :@0.387827:0.572740:0.746209:0.572740:0.746209:0.561263:0.387827:0.561263:0.004542:0.007958:0.007255:0.004592:0.011797:0.006356:0.006356:0.008170:0.007516:0.004542:0.007255:0.004542:0.004542:0.008170:0.008366:0.003513:0.008987:0.005964:0.001961:0.004542:0.008170:0.007255:0.004297:0.011193:0.005441:0.004771:0.004542:0.004542:0.006683:0.008333:0.003186:0.009085:0.008170:0.007255:0.005441:0.012712:0.007255:0.007255:0.007255:0.008170:0.004542:0.004542:0.007255:0.007255:0.004542:0.004330:0.005441:0.007958:0.008170:0.008007:0.006356:0.004346:0.005441:0.008170:0.004085
(ABPI);:@0.747059:0.572194:0.787961:0.572194:0.787961:0.563013:0.747059:0.563013:0.004353:0.009046:0.008497:0.007033:0.004170:0.004170:0.003634
• :@0.341176:0.601843:0.349592:0.601843:0.349592:0.590366:0.341176:0.590366:0.004330:0.004085
to advise Local Research Ethics Committees :@0.387827:0.601843:0.683056:0.601843:0.683056:0.590366:0.387827:0.590366:0.004330:0.007843:0.005065:0.007255:0.007859:0.008007:0.004542:0.006078:0.007255:0.004085:0.009984:0.008170:0.007255:0.007255:0.004542:0.004085:0.010899:0.007467:0.006356:0.007451:0.007255:0.005441:0.007484:0.008170:0.003350:0.009984:0.004542:0.008170:0.004542:0.007255:0.006356:0.004984:0.010703:0.008170:0.012337:0.012500:0.004542:0.004363:0.004542:0.007059:0.007255:0.006356:0.004085
(LRECs) :@0.683905:0.601298:0.733827:0.601298:0.733827:0.592116:0.683905:0.592116:0.004353:0.007987:0.008719:0.007699:0.008719:0.005085:0.004092:0.003268
of the standard form of :@0.734475:0.601843:0.889949:0.601843:0.889949:0.590366:0.734475:0.590366:0.008987:0.005964:0.002369:0.004542:0.007958:0.007255:0.004918:0.006356:0.004542:0.007255:0.008170:0.008170:0.007255:0.005441:0.008170:0.003464:0.005441:0.008448:0.005441:0.013186:0.003595:0.008660:0.005801:0.004085
agreement.:@0.388250:0.619708:0.458642:0.619708:0.458642:0.608231:0.388250:0.608231:0.007026:0.007925:0.005229:0.007255:0.006961:0.012337:0.007255:0.007778:0.004542:0.004085
Section Two:@0.293709:0.664631:0.447062:0.664631:0.447062:0.644336:0.293709:0.644336:0.016088:0.013059:0.012765:0.009794:0.007941:0.014471:0.016088:0.008647:0.019118:0.020676:0.014706
1. :@0.295245:0.699381:0.309951:0.699381:0.309951:0.687904:0.295245:0.687904:0.007108:0.003513:0.004085
A wide variety of clinical studies involving experimental or investigational use of drugs :@0.340752:0.699381:0.918203:0.699381:0.918203:0.687904:0.340752:0.687904:0.011797:0.003889:0.011601:0.004542:0.008170:0.007059:0.003922:0.008170:0.007435:0.005441:0.004542:0.007255:0.004542:0.008170:0.004690:0.008905:0.005964:0.002778:0.007255:0.004542:0.004542:0.008007:0.004542:0.007255:0.007075:0.004542:0.004771:0.006356:0.004265:0.007925:0.007925:0.004542:0.007059:0.006356:0.004592:0.004542:0.008170:0.008170:0.008170:0.004542:0.008170:0.004542:0.008170:0.008170:0.004085:0.007255:0.007958:0.008170:0.007255:0.005441:0.004542:0.012712:0.007255:0.008170:0.004542:0.007255:0.004542:0.004085:0.008627:0.005637:0.003513:0.004542:0.008170:0.008170:0.007059:0.006356:0.004542:0.004542:0.008170:0.007255:0.004542:0.004379:0.008170:0.008007:0.007255:0.004542:0.003889:0.008170:0.006356:0.007042:0.004739:0.008905:0.005964:0.002778:0.008170:0.005229:0.008007:0.008170:0.006127:0.004085
is carried out within NHS bodies. This includes studies in patients (clinical trials) and :@0.340752:0.717246:0.903088:0.717246:0.903088:0.705769:0.340752:0.705769:0.004542:0.006078:0.004330:0.007255:0.007255:0.005441:0.005441:0.004542:0.007255:0.008170:0.004085:0.008170:0.008170:0.004804:0.003513:0.011797:0.004788:0.004542:0.008366:0.004542:0.008170:0.003301:0.011601:0.011601:0.008905:0.004330:0.008170:0.008170:0.008007:0.004542:0.007059:0.006356:0.004085:0.005408:0.009804:0.008007:0.004542:0.006356:0.004085:0.004542:0.008170:0.006944:0.004542:0.008170:0.007958:0.007255:0.006356:0.005016:0.006356:0.004265:0.007925:0.007925:0.004542:0.007059:0.006356:0.004592:0.004820:0.008497:0.003105:0.008170:0.007255:0.004346:0.004542:0.007255:0.008170:0.004542:0.006356:0.005082:0.005441:0.006977:0.004542:0.004542:0.007908:0.004542:0.006977:0.007255:0.004346:0.003922:0.004542:0.005441:0.004542:0.007042:0.004542:0.006160:0.005441:0.005016:0.007255:0.007941:0.008170:0.004085
studies in healthy human volunteers. They may involve administration of a totally new :@0.341160:0.735176:0.910359:0.735176:0.910359:0.723698:0.341160:0.723698:0.006356:0.004346:0.008007:0.008170:0.004330:0.007255:0.006356:0.004085:0.004935:0.008497:0.003513:0.008007:0.007255:0.007255:0.004281:0.004542:0.008170:0.007958:0.004739:0.008170:0.008170:0.012908:0.007255:0.008170:0.002794:0.008170:0.008170:0.004542:0.008170:0.007958:0.004542:0.007255:0.007075:0.005441:0.006356:0.004085:0.005441:0.009804:0.008007:0.007255:0.007859:0.004739:0.012418:0.007026:0.008170:0.004085:0.004542:0.008170:0.008170:0.008170:0.004363:0.008170:0.007255:0.004592:0.007255:0.008350:0.012712:0.004542:0.008170:0.004542:0.006356:0.004542:0.005441:0.007255:0.004542:0.004542:0.008350:0.008170:0.003268:0.008905:0.005964:0.002778:0.007435:0.003513:0.004542:0.008170:0.004363:0.007255:0.004542:0.004542:0.008170:0.004657:0.008170:0.007026:0.011520:0.004085
(unlicensed) drug (active substance or ~NAS’) or the administration of an established :@0.341160:0.753105:0.902925:0.753105:0.902925:0.741628:0.341160:0.741628:0.005441:0.008170:0.007876:0.004542:0.004363:0.007255:0.007042:0.008007:0.006356:0.007255:0.007876:0.005441:0.004690:0.008170:0.005441:0.008170:0.008170:0.004085:0.005441:0.007010:0.007255:0.004346:0.004542:0.007876:0.007255:0.005000:0.006356:0.007941:0.008170:0.006356:0.004265:0.007255:0.008170:0.007042:0.007255:0.004592:0.008497:0.005637:0.003186:0.009150:0.012173:0.012092:0.009314:0.004330:0.004657:0.004739:0.008497:0.005637:0.003513:0.004542:0.007958:0.007255:0.004510:0.007255:0.008350:0.012712:0.004542:0.008170:0.004542:0.006356:0.004542:0.005441:0.007451:0.004542:0.004542:0.008170:0.008170:0.003252:0.008987:0.005964:0.002696:0.007598:0.008497:0.003513:0.007255:0.006356:0.004542:0.007255:0.008007:0.004542:0.004542:0.006356:0.008170:0.007255:0.007941:0.004085
(licensed) drug by a novel route, for a new therapeutic indication, or in a novel :@0.340752:0.770907:0.857958:0.770907:0.857958:0.759429:0.340752:0.759429:0.005441:0.004281:0.004542:0.007255:0.006993:0.008170:0.006356:0.007042:0.008170:0.005441:0.004935:0.008170:0.005441:0.008170:0.008170:0.002974:0.008170:0.008333:0.004739:0.007435:0.003922:0.008170:0.008170:0.008007:0.007255:0.004542:0.004085:0.005441:0.008170:0.007843:0.004542:0.006977:0.004085:0.004248:0.005719:0.008578:0.005719:0.003513:0.007435:0.003922:0.008170:0.007255:0.011797:0.003415:0.004542:0.008170:0.007255:0.005441:0.007255:0.008170:0.007255:0.008170:0.004542:0.004542:0.007255:0.004281:0.004542:0.008170:0.008170:0.004281:0.007255:0.007255:0.004281:0.004542:0.008170:0.007958:0.004085:0.004984:0.008497:0.005637:0.003513:0.004820:0.008497:0.003513:0.007516:0.003922:0.008007:0.007925:0.007925:0.007026:0.004542:0.004085
formulation or combination.:@0.340343:0.788456:0.523595:0.788456:0.523595:0.776979:0.340343:0.776979:0.005441:0.008366:0.005441:0.012941:0.008170:0.004542:0.007467:0.004542:0.004542:0.008399:0.008170:0.003595:0.008170:0.005441:0.004085:0.006977:0.007925:0.012418:0.008007:0.004542:0.007958:0.007255:0.004265:0.004542:0.007958:0.008007:0.004085
2. :@0.294118:0.824571:0.309559:0.824571:0.309559:0.813093:0.294118:0.813093:0.007598:0.003758:0.004085
Detailed guidance on the design, conduct, and ethical implications of clinical studies is :@0.340033:0.824571:0.911520:0.824571:0.911520:0.813093:0.340033:0.813093:0.011797:0.007255:0.004542:0.007451:0.004542:0.004542:0.007255:0.008170:0.004085:0.008007:0.008170:0.004330:0.008170:0.006944:0.008170:0.007026:0.007255:0.004592:0.008415:0.008497:0.003105:0.004542:0.008170:0.007255:0.004706:0.007925:0.007255:0.006062:0.004542:0.007794:0.007925:0.004085:0.005065:0.007255:0.008170:0.007859:0.008007:0.008007:0.007255:0.004346:0.004085:0.004984:0.007255:0.008170:0.008170:0.003856:0.007255:0.004542:0.008170:0.004542:0.007255:0.007255:0.004542:0.004314:0.004542:0.012712:0.008170:0.004542:0.004542:0.007255:0.007255:0.004542:0.004542:0.008170:0.008170:0.006356:0.004085:0.009150:0.005964:0.002696:0.007255:0.004346:0.004542:0.008170:0.004542:0.007255:0.007255:0.004542:0.005033:0.006127:0.004542:0.007876:0.008170:0.004330:0.007255:0.006062:0.004248:0.004248:0.005964:0.004085
given in::@0.340359:0.842436:0.396373:0.842436:0.396373:0.830958:0.340359:0.830958:0.008170:0.004542:0.008170:0.007255:0.008382:0.003105:0.004248:0.007598:0.004542
HSG(91)5:  Local Research Ethics Committees:@0.387418:0.877601:0.702042:0.877601:0.702042:0.866111:0.387418:0.866111:0.011797:0.007974:0.011797:0.005196:0.008170:0.008007:0.005441:0.008170:0.005261:0.004085:0.009641:0.009314:0.008415:0.007516:0.008415:0.004739:0.002778:0.009984:0.007255:0.006356:0.007255:0.008170:0.006356:0.007255:0.008170:0.004314:0.009984:0.004804:0.008333:0.004542:0.007255:0.006585:0.004330:0.010703:0.008170:0.011797:0.011797:0.004542:0.004542:0.004542:0.007255:0.007255:0.006356
 (with accompanying booklet). :@0.701961:0.877601:0.905033:0.877601:0.905033:0.866124:0.701961:0.866124:0.004739:0.005441:0.011797:0.004542:0.004542:0.008170:0.003497:0.007255:0.007255:0.007255:0.008170:0.012712:0.008170:0.007255:0.008170:0.008170:0.004542:0.008170:0.008170:0.003154:0.008170:0.008170:0.007843:0.008170:0.004330:0.007255:0.004346:0.005441:0.004085:0.004085
NHS Executive:  1991;:@0.387418:0.894836:0.535833:0.894836:0.535833:0.883359:0.387418:0.883359:0.011797:0.011797:0.009085:0.004575:0.009641:0.007925:0.007255:0.006961:0.008007:0.004542:0.004363:0.008170:0.006944:0.004542:0.004085:0.002892:0.007761:0.007843:0.007843:0.007843:0.004542
Guidelines for Medical Experiments in non-Patient Human Volunteers:@0.389788:0.926654:0.851422:0.926654:0.851422:0.915164:0.389788:0.915164:0.011797:0.007974:0.004542:0.008170:0.007255:0.004542:0.004542:0.008170:0.007255:0.006356:0.003497:0.004542:0.008529:0.006536:0.003595:0.013611:0.007255:0.008170:0.004788:0.007255:0.008350:0.004542:0.003219:0.009984:0.007255:0.008333:0.007255:0.006552:0.004542:0.011797:0.007255:0.008350:0.004542:0.006356:0.004085:0.004297:0.007843:0.004330:0.008170:0.008333:0.008333:0.005441:0.010245:0.008333:0.004542:0.004542:0.007500:0.008333:0.004542:0.002892:0.011797:0.008170:0.011797:0.008170:0.008170:0.004428:0.009984:0.007990:0.004542:0.008170:0.008170:0.004542:0.007255:0.007255:0.006356:0.006356