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clinical trials notes pdf %}�@�`P�ї�њ�����>[Fl0"�@��ؾ�($�CJ{����mzO�\.�g)�1����,��. Note: This definition includes biologicals used as investigational medicinal products. •Randomized clinical trials are gold standard for testing a hypothesis, but there are significant limitations: • generalizability • timeliness • cost $$$ Cost of Randomized Clinical Trials • Estimated cost of RCT: ® Drug Trial: $15,000/patient • 1000 patient trial: $15MM • Simply too expensive to answer every relevent clinical question with prospective blinded RCT. The manuscript must contain an Abstract (unstructured, 250 words), Introduction (500 words), Methods (no word limit), Results (no word limit), Discussion (1,500 words), Acknowledgments, and References. clinical trial facilities for clinicians and researchers to conduct trials. INTRODUCTION • Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy of any new drug. See listed clinical studies related to the coronavirus disease (COVID-19) ClinicalTrials.gov is a resource provided by the U.S. National Library of Medicine. All clinical research starts with the research protocol, a document that details all aspects of the trial: its background, rationale, objectives, design, methodology, statistical analysis plan, and organization.With the protocol, you can make sure you protect the participants and collect the data. From ‘Note to Self: No More Notes to File’ by Carl Anderson, Applied Clinical Trials, March 2008 “A common document at many clinical sites is the memo or note to file (NTF). ��f^�cS[�\yi��ʔ��{���0�Ea�,�ߠ��Xm���P���s��e�����W��X䛒C�0�S���g8�b\�� ��X#C�?Q�������>oj]��%��YVԵus�F��́ 0 In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the E6(R2) addendum text should take priority. Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 7/68 1. Clinical endocrinology notes — calcium and bone metabolism, diabetes, thyroid disorders, pituitary disorders, adrenal disorders, neuroendocrine tumors etc. However, as in any clinical situation, there may be factors which cannot be covered by a single set of guidelines. Reviewed by the QH Clinical Research Coordinators Network May 2010 . Vaccine effectiveness against long-term effects of COVID-19 disease h�b```b``�f`e``�eb@ !�Gc�� �P���=2�k.h���dJb8����.5y���{By��lx�2��Q��I�4�p�W�rp6``P��aĕ=Wܒ�I��Ѿh>�U+D&dŶ��4��θr��J�ɒ���[���-��,Y�#�@�)KS�HT�Gjz�ڒέ�m�bRK:�=nug\�6�s�X��*ۂY� �?�2�&/���W���怴(�YDֺ3�l[��v�����ۀ䬸mצ�k�ݰ�>��U�A�Yk+f�.��rR�X���SAn[�p��ĝˁ��Y�+�v���� � #���k�.] It outlines all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. L.E.K. gives no representation or warranty as to the reliability or completeness of the Report. File format should be Microsoft Word, and manuscript pages should be numbered within the Word file. Director, Biostatistics Unit, Clinical Research Institute Director, Fellowship and Residency Research Program American University of Beirut Medical Center PO Box 11-0236 (F15) Riad El Solh, Beirut 1107 2020 Beirut, Lebanon E-mail: hani_t@hotmail.com, htamim@aub.edu.lb . X\;ôw×æݵWÚ9ª¥‹+í´•þqórN VõŽj–¹—Žb lMmÚitrª¤›Ë^²™a— PZ®mq`Óé\H”Ø‘›¾hwøg§‡¼œ•›Ì¡ë¤}íØڈ¡ žçå¬#1ÈYÏh±+Uõ£a£ëXYU$¼Úñ–a CÙÏE÷n ƒuŠ%ÅÞCU‚5¸Ž`†Ñ¼bÑ”#àaœ³å²ÿ×9a> ”iV°`Ðê@ù¶°ä*h£¶°š­`ÀŒLU0Ð×ãL°ÖÙ§^­ÖaøÞ6`M. Procedure: Clinical Research - Use of Electronic Signatures This document reflects what is currently regarded as safe practice. Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the new medication is meant to treat. clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, a new patient group or when used to gain further information about an approved use. +��+2�Œژ��� ��\�0�4~$BH�#vԚb���u¯��ٝl$x�b#��Gndέ!�>)p4tφ��u+�W�`���*�4�GM -�$m����9���]M��a���C�B:���Fbf=�� �G��ZA��c`y��u�\+@ƵZL�\�` �oi����6����j�L�;�T��e� �:���bf���v�,{��騈���e��egy � H�|W�n%� |?_я� n��DI�b��\6�`�!��1�ˬ׻A�>d�����Y3�u��Y�~:�%-u�U�-�����ts���p��p�����ͧ�_�����o������w�i�����Kk�Ҫ���+_H|!e���m�ܗj������wk���{j^��̗�s�be�]�v��� ����#����W� ���9�����Z��{̿?���'�o��k�����}uy�x���a�⋋? Edited by D. Machin, S. Day and S. Green 2004 John Wiley & Sons, Ltd ISBN: 0-471-98787-5. Why conduct a clinical trial in Australia? In 2014, NHMRC engaged Rallis Legal to review indemnity and insurance arrangements for clinical trials in the public and private sectors. It boasts world-class medical research and healthcare infrastructure, a stable socioeconomic environment, an ethnically diverse population and a strong intellectual property regime. Çþ(—–2õÕ¢õeØþÊçÀ²_ø”ûfï¯-˜Þêa«ŸÞcþÊ×ÎÕöBÿ^)(øån£þþõJE]gÛ^]÷ܽXÛ¾ý)½û^/Ðý˜aç\Ç»ýõøNϾeŽ-sü—/ž÷ZŽÏ>àå_ˆ*Ê:¥q$dõ8Zˆ²ÎcøéÖƯå°ü$žpæ°Ï£sX¨žì,±˜µÒpq,þ^zÿ\#Ž÷\;K=žêYàþF=e¹¬(ºŒ2¸Öá¨ó)KK]ÆÂ+qú2Y6¹¶ ��L�q�L���N`�`��```���h ��Z�������+�+HY(�2T�jS�@�T�gɃla`PE����� +�A-����E:3�}�'+�H?s����XF��ߖTq����o��K{?Z�^;$ì� ��dз���,A�������~��ܵ�1v�N0xT���0�����[�n,��c`zV� N�B��t.�b ��O���fQ�x ]��):�g��y�$�4?C�,�4�u ;8�NA�1 zJz has not updated the Report to take account of events and circumstances that may have occurred since preparation of the Report. Trials in this phase can last for several years. ~�����(�8w4F����:� �A� A progress note is similar to a doctor and medical note where healthcare professionals record details to document patient’s clinical status during the patient’s stay for hospitalization or over the course of outpatient care. ��21�����ءhd��s>�0�����)/��B� �*�|$. h�bbd```b``� "�A$��d��́`�8�4��� ��̞$ ��l�=`��`6�d޿ Rl:He�;�D&�m� �\�@��'&F6G��I endstream endobj 1719 0 obj <>stream Section 1: Overview of the research process 2 Section 1: Overview of the research process 1. infection, including data from clinical trials and from the vaccine’s use post-authorization. Biological. When used properly, an NTF can be a positive practice. Following the 305 application, the Center for Drug Evaluation and Research (CDER) has 30 days to 306 review the IND and approve for clinical trials. Title page. ]=|X��_�����_}�����鼔������T���EF�!�Wy���������oo�^�?�c�on���%^���?>�>?>ݺͫ�wNħǧ�@�����������y}������o�]��Ne�ivZu9�5].߹��۫��}�3X���ǻ_���Ǜ��O7���|����SZ�VSY(ujK����Y٢�76V���k�]�_v�d�2����]�����i�t��9+�q�����n?��t�aN7s?�]]߼�޽���hZ0��±�y�������bv�{D���e[Zn�H��G�S-�Z-T��"�>z4G(x��Q��H��'���_��M�G�}�5������1�s}_��ؕ�1 �=��Tb�M�JYk�����~|�R���`^{�撏a����&������k��TZ�}�u�U1Y\v*�Jk�y�n=(� �h�D��N|O�,NR+#8s�����,`^v�1�# ;�>���&.�{��]�lc'�F�G��� 8�$ �dBO����� ���_$�mX��]|�����}��m����JL���)NU,���޾\�z���q2��؃K�y]���\2@��Ԉ���1m�LJe�q��⛙�� Textbook of Clinical Trials Textbook of Clinical Trials. The information below may be helpful if you are thinking about conducting a clinical trial in Australia. It is supported by experienced private sector service providers covering all aspects of clinical trial management. UJJɓ���S�v�v�KFe���~�ē�o�.�ܾt���:5k��/ן'�oڤ�:��ƾ�>Y=�/SW�:R�ě�%�l�Z! What is a Clinical trial? %%EOF The healthcare professionals write the progress note in a different format depending on the clinical situation at hand. Glossary 1.1. Clinical Trial Any research study that prospectively assigns human participants or groups of humans to one or more healthrelated - interventions to evaluatethe effects on health outcomes. “In summary, Clinical Trials Handbook is a user friendly book with numerous examples from the real clinical trials. Procedure: Clinical Research - Financial Management This document reflects what is currently regarded as safe practice. You may only use the Report for your own personal information, research or study, subject to the notes, context and disclaimers therein. More than 85 core biotechnology companies and 80 biotechnology-related research organisations make up a dynamic early stage private sector engaged in collaborative drug development. Clinical Trial Capability Report(PDF)(AusTrade) 1736 0 obj <>/Filter/FlateDecode/ID[]/Index[1713 222]/Info 1712 0 R/Length 130/Prev 601868/Root 1714 0 R/Size 1935/Type/XRef/W[1 3 1]>>stream 7. endstream endobj startxref Note: When registering as a site administrator, select all the clinical departments where clinical trials are conducted within your health service organisation. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. 4 CLINICAL TRIALS Australia is home to some of the world’s leading scientists, physicians and healthcare professionals. 2. L.E.K. • prospective ethically designed investigation in It human subjects to objectively discover/verify/compare the results of two or more therapeutic measures (drugs) • A clinical trial is a planned experiment that involves volunteers/patients • Aim to compare the response to new treatment with that of an existing one or placebo • Clinical trial is just a part of New Drug Discovery … There are different types of clinical trials, including: treatment trials to test new treatments, new medicines or combinations of medicines; or other new therapies such as surgery, the use of new medical devices or new approaches to surgery diagnostic or screening trials to evaluate tests or procedures to diagnose and detect diseases or conditions prevention trials to test Microsoft Word, and manuscript pages should be Microsoft Word, and manuscript pages be... Gives no representation or warranty as to the coronavirus disease ( COVID-19 ) clinicaltrials.gov is a provided... 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clinical trials notes pdf

Clinical Notes Brief reports on clinical cases. endstream endobj 1718 0 obj <>stream endstream endobj 1714 0 obj <>/Metadata 127 0 R/Names 1738 0 R/OpenAction 1715 0 R/Outlines 1751 0 R/PageLabels 1703 0 R/PageLayout/SinglePage/PageMode/UseOutlines/Pages 1706 0 R/StructTreeRoot 263 0 R/Type/Catalog/ViewerPreferences<>>> endobj 1715 0 obj <> endobj 1716 0 obj <>/Font<>/ProcSet[/PDF/Text]/Properties<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/TrimBox[0.0 0.0 595.276 841.89]/Type/Page>> endobj 1717 0 obj <>stream [��$�8:�4��6N��$�V�f�Ի"�b���y;;� �x(|���g��������o��://���#���ڤ��?2�}\\�l�U�����–6Klu(,�mk� H�\��n�@E���LwW%Br�D�b�| ���j��~�r��4H�ATU���l���~���8��0�c?t1\�kl�=�S?���]�����ڞ��d)y������*��J//s�هu7£�~�.�~8ه?������i��0�6�um�pL��5���l��=�����oO)�_���l��i�.\�� �N�Ty:j[���6a��{�s���GMU���I�Km�2_��-�3��B^b��-����x��rW� ���"��������B�N�Xӡ�cM���5j:�t��Xǡ��������������H7Sy��ы�Zky�屖�Zk �n�xA�0^/��%�� Siebel Clinical Trial Management System Guide Siebel Innovation Pack 2014 5 Terminating Clinical Trials Early for Clinical Subjects 75 Applying Protocol Amendments to Sites and Clinical Subjects 76 Applying Revised Subject Visit Templates to Sites 77 Applying Revised Subject Visit Templates to Clinical Subjects 77 Rules for Applying Protocol Amendments 78 Rules for Deleting Subject Visits … g���Y�pV:+�����O�0��5��5�4�˖Z���k�M�dSN�W� ���� particular mention is the Note for Guidance with respect to Clinical Safety Data Management, describing the reporting processes for expedited reporting of Adverse Drug Reactions (ADRs) in clinical trials.6 Reporting procedures are also summarised in this handbook. This document does not replace the need for the application of clinical judgement to each individual presentation. �9�B�>%}�@�`P�ї�њ�����>[Fl0"�@��ؾ�($�CJ{����mzO�\.�g)�1����,��. Note: This definition includes biologicals used as investigational medicinal products. •Randomized clinical trials are gold standard for testing a hypothesis, but there are significant limitations: • generalizability • timeliness • cost $$$ Cost of Randomized Clinical Trials • Estimated cost of RCT: ® Drug Trial: $15,000/patient • 1000 patient trial: $15MM • Simply too expensive to answer every relevent clinical question with prospective blinded RCT. The manuscript must contain an Abstract (unstructured, 250 words), Introduction (500 words), Methods (no word limit), Results (no word limit), Discussion (1,500 words), Acknowledgments, and References. clinical trial facilities for clinicians and researchers to conduct trials. INTRODUCTION • Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy of any new drug. See listed clinical studies related to the coronavirus disease (COVID-19) ClinicalTrials.gov is a resource provided by the U.S. National Library of Medicine. All clinical research starts with the research protocol, a document that details all aspects of the trial: its background, rationale, objectives, design, methodology, statistical analysis plan, and organization.With the protocol, you can make sure you protect the participants and collect the data. From ‘Note to Self: No More Notes to File’ by Carl Anderson, Applied Clinical Trials, March 2008 “A common document at many clinical sites is the memo or note to file (NTF). ��f^�cS[�\yi��ʔ��{���0�Ea�,�ߠ��Xm���P���s��e�����W��X䛒C�0�S���g8�b\�� ��X#C�?Q�������>oj]��%��YVԵus�F��́ 0 In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the E6(R2) addendum text should take priority. Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 7/68 1. Clinical endocrinology notes — calcium and bone metabolism, diabetes, thyroid disorders, pituitary disorders, adrenal disorders, neuroendocrine tumors etc. However, as in any clinical situation, there may be factors which cannot be covered by a single set of guidelines. Reviewed by the QH Clinical Research Coordinators Network May 2010 . Vaccine effectiveness against long-term effects of COVID-19 disease h�b```b``�f`e``�eb@ !�Gc�� �P���=2�k.h���dJb8����.5y���{By��lx�2��Q��I�4�p�W�rp6``P��aĕ=Wܒ�I��Ѿh>�U+D&dŶ��4��θr��J�ɒ���[���-��,Y�#�@�)KS�HT�Gjz�ڒέ�m�bRK:�=nug\�6�s�X��*ۂY� �?�2�&/���W���怴(�YDֺ3�l[��v�����ۀ䬸mצ�k�ݰ�>��U�A�Yk+f�.��rR�X���SAn[�p��ĝˁ��Y�+�v���� � #���k�.] It outlines all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. L.E.K. gives no representation or warranty as to the reliability or completeness of the Report. File format should be Microsoft Word, and manuscript pages should be numbered within the Word file. Director, Biostatistics Unit, Clinical Research Institute Director, Fellowship and Residency Research Program American University of Beirut Medical Center PO Box 11-0236 (F15) Riad El Solh, Beirut 1107 2020 Beirut, Lebanon E-mail: hani_t@hotmail.com, htamim@aub.edu.lb . X\;ôw×æݵWÚ9ª¥‹+í´•þqórN VõŽj–¹—Žb lMmÚitrª¤›Ë^²™a— PZ®mq`Óé\H”Ø‘›¾hwøg§‡¼œ•›Ì¡ë¤}íØڈ¡ žçå¬#1ÈYÏh±+Uõ£a£ëXYU$¼Úñ–a CÙÏE÷n ƒuŠ%ÅÞCU‚5¸Ž`†Ñ¼bÑ”#àaœ³å²ÿ×9a> ”iV°`Ðê@ù¶°ä*h£¶°š­`ÀŒLU0Ð×ãL°ÖÙ§^­ÖaøÞ6`M. Procedure: Clinical Research - Use of Electronic Signatures This document reflects what is currently regarded as safe practice. Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the new medication is meant to treat. clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, a new patient group or when used to gain further information about an approved use. +��+2�Œژ��� ��\�0�4~$BH�#vԚb���u¯��ٝl$x�b#��Gndέ!�>)p4tφ��u+�W�`���*�4�GM -�$m����9���]M��a���C�B:���Fbf=�� �G��ZA��c`y��u�\+@ƵZL�\�` �oi����6����j�L�;�T��e� �:���bf���v�,{��騈���e��egy � H�|W�n%� |?_я� n��DI�b��\6�`�!��1�ˬ׻A�>d�����Y3�u��Y�~:�%-u�U�-�����ts���p��p�����ͧ�_�����o������w�i�����Kk�Ҫ���+_H|!e���m�ܗj������wk���{j^��̗�s�be�]�v��� ����#����W� ���9�����Z��{̿?���'�o��k�����}uy�x���a�⋋? Edited by D. Machin, S. Day and S. Green 2004 John Wiley & Sons, Ltd ISBN: 0-471-98787-5. Why conduct a clinical trial in Australia? In 2014, NHMRC engaged Rallis Legal to review indemnity and insurance arrangements for clinical trials in the public and private sectors. It boasts world-class medical research and healthcare infrastructure, a stable socioeconomic environment, an ethnically diverse population and a strong intellectual property regime. Çþ(—–2õÕ¢õeØþÊçÀ²_ø”ûfï¯-˜Þêa«ŸÞcþÊ×ÎÕöBÿ^)(øån£þþõJE]gÛ^]÷ܽXÛ¾ý)½û^/Ðý˜aç\Ç»ýõøNϾeŽ-sü—/ž÷ZŽÏ>àå_ˆ*Ê:¥q$dõ8Zˆ²ÎcøéÖƯå°ü$žpæ°Ï£sX¨žì,±˜µÒpq,þ^zÿ\#Ž÷\;K=žêYàþF=e¹¬(ºŒ2¸Öá¨ó)KK]ÆÂ+qú2Y6¹¶ ��L�q�L���N`�`��```���h ��Z�������+�+HY(�2T�jS�@�T�gɃla`PE����� +�A-����E:3�}�'+�H?s����XF��ߖTq����o��K{?Z�^;$ì� ��dз���,A�������~��ܵ�1v�N0xT���0�����[�n,��c`zV� N�B��t.�b ��O���fQ�x ]��):�g��y�$�4?C�,�4�u ;8�NA�1 zJz has not updated the Report to take account of events and circumstances that may have occurred since preparation of the Report. Trials in this phase can last for several years. ~�����(�8w4F����:� �A� A progress note is similar to a doctor and medical note where healthcare professionals record details to document patient’s clinical status during the patient’s stay for hospitalization or over the course of outpatient care. ��21�����ءhd��s>�0�����)/��B� �*�|$. h�bbd```b``� "�A$��d��́`�8�4��� ��̞$ ��l�=`��`6�d޿ Rl:He�;�D&�m� �\�@��'&F6G��I endstream endobj 1719 0 obj <>stream Section 1: Overview of the research process 2 Section 1: Overview of the research process 1. infection, including data from clinical trials and from the vaccine’s use post-authorization. Biological. When used properly, an NTF can be a positive practice. Following the 305 application, the Center for Drug Evaluation and Research (CDER) has 30 days to 306 review the IND and approve for clinical trials. Title page. ]=|X��_�����_}�����鼔������T���EF�!�Wy���������oo�^�?�c�on���%^���?>�>?>ݺͫ�wNħǧ�@�����������y}������o�]��Ne�ivZu9�5].߹��۫��}�3X���ǻ_���Ǜ��O7���|����SZ�VSY(ujK����Y٢�76V���k�]�_v�d�2����]�����i�t��9+�q�����n?��t�aN7s?�]]߼�޽���hZ0��±�y�������bv�{D���e[Zn�H��G�S-�Z-T��"�>z4G(x��Q��H��'���_��M�G�}�5������1�s}_��ؕ�1 �=��Tb�M�JYk�����~|�R���`^{�撏a����&������k��TZ�}�u�U1Y\v*�Jk�y�n=(� �h�D��N|O�,NR+#8s�����,`^v�1�# ;�>���&.�{��]�lc'�F�G��� 8�$ �dBO����� ���_$�mX��]|�����}��m����JL���)NU,���޾\�z���q2��؃K�y]���\2@��Ԉ���1m�LJe�q��⛙�� Textbook of Clinical Trials Textbook of Clinical Trials. The information below may be helpful if you are thinking about conducting a clinical trial in Australia. It is supported by experienced private sector service providers covering all aspects of clinical trial management. UJJɓ���S�v�v�KFe���~�ē�o�.�ܾt���:5k��/ן'�oڤ�:��ƾ�>Y=�/SW�:R�ě�%�l�Z! What is a Clinical trial? %%EOF The healthcare professionals write the progress note in a different format depending on the clinical situation at hand. Glossary 1.1. Clinical Trial Any research study that prospectively assigns human participants or groups of humans to one or more healthrelated - interventions to evaluatethe effects on health outcomes. “In summary, Clinical Trials Handbook is a user friendly book with numerous examples from the real clinical trials. Procedure: Clinical Research - Financial Management This document reflects what is currently regarded as safe practice. You may only use the Report for your own personal information, research or study, subject to the notes, context and disclaimers therein. More than 85 core biotechnology companies and 80 biotechnology-related research organisations make up a dynamic early stage private sector engaged in collaborative drug development. Clinical Trial Capability Report(PDF)(AusTrade) 1736 0 obj <>/Filter/FlateDecode/ID[]/Index[1713 222]/Info 1712 0 R/Length 130/Prev 601868/Root 1714 0 R/Size 1935/Type/XRef/W[1 3 1]>>stream 7. endstream endobj startxref Note: When registering as a site administrator, select all the clinical departments where clinical trials are conducted within your health service organisation. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. 4 CLINICAL TRIALS Australia is home to some of the world’s leading scientists, physicians and healthcare professionals. 2. L.E.K. • prospective ethically designed investigation in It human subjects to objectively discover/verify/compare the results of two or more therapeutic measures (drugs) • A clinical trial is a planned experiment that involves volunteers/patients • Aim to compare the response to new treatment with that of an existing one or placebo • Clinical trial is just a part of New Drug Discovery … There are different types of clinical trials, including: treatment trials to test new treatments, new medicines or combinations of medicines; or other new therapies such as surgery, the use of new medical devices or new approaches to surgery diagnostic or screening trials to evaluate tests or procedures to diagnose and detect diseases or conditions prevention trials to test Microsoft Word, and manuscript pages should be Microsoft Word, and manuscript pages be... Gives no representation or warranty as to the coronavirus disease ( COVID-19 ) clinicaltrials.gov is a provided... 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