These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

141 related articles for article (PubMed ID: 33997463)

  • 1. Stakeholders' recommendations for revising Good Clinical Practice.
    Corneli A; Forrest A; Swezey T; Lin L; Tenaerts P
    Contemp Clin Trials Commun; 2021 Jun; 22():100776. PubMed ID: 33997463
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Stakeholders' views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2).
    Dombeck C; Swezey T; Forrest A; Tenaerts P; Corneli A
    Contemp Clin Trials Commun; 2022 Oct; 29():100983. PubMed ID: 36111176
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation.
    Nakamura K; Ozawa H; Shibata T; Ushirozawa N; Hata T; Okita N; Fuse N; Sato N; Ikeda K; Hanaoka H; Maruyama T; Wada M; Shimizu S; Kasai H; Yamamoto Y; Sakurai J; Todaka K; Tashiro S; Yamamoto H
    Ther Innov Regul Sci; 2022 Mar; 56(2):220-229. PubMed ID: 34787814
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates.
    Bechtel J; Chuck T; Forrest A; Hildebrand C; Panhuis J; Pattee SR; Comic-Savic S; Swezey T
    Contemp Clin Trials; 2020 Feb; 89():105918. PubMed ID: 31881391
    [TBL] [Abstract][Full Text] [Related]  

  • 5. International Council for Harmonisation E6(R2) addendum: Challenges of implementation.
    Bhatt A
    Perspect Clin Res; 2017; 8(4):162-166. PubMed ID: 29109932
    [TBL] [Abstract][Full Text] [Related]  

  • 6. [ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives].
    Englev E; Petersen KP
    Ugeskr Laeger; 2003 Apr; 165(16):1659-62. PubMed ID: 12756823
    [TBL] [Abstract][Full Text] [Related]  

  • 7. General Principles for the Education and Training of GCP Inspectors: The Outcome of Discussions by International Regulatory Experts in the Discussion Group on the ICH E6 Guideline.
    Uyama Y; Yamazaki E; Clark K; Wang CY; Woro E; Tong FY; Sachidanandan S; Rodriguez A; Oh H; Saleh K; Cirunay J; Wapeewuttikorn A; Rogov E; Alshahwan KW; Herrera I; Mthetwa J; Fakudze F; Osawa T
    Ther Innov Regul Sci; 2015 Mar; 49(2):249-253. PubMed ID: 30222411
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Good intentions and ICH-GCP: Trial conduct training needs to go beyond the ICH-GCP document and include the intention-to-treat principle.
    Browne LH; Graham PH
    Clin Trials; 2014 Dec; 11(6):629-34. PubMed ID: 25023199
    [TBL] [Abstract][Full Text] [Related]  

  • 9. More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant.
    Swezey T; McGuire FH; Hurley P; Panhuis J; Goldstein K; Chuck T; Dombeck C; Perry B; Brennan C; Phrsai N; Corneli A
    Contemp Clin Trials Commun; 2020 Sep; 19():100606. PubMed ID: 32817904
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development.
    Bhagat R; Bojarski L; Chevalier S; Görtz DR; Le Meignen S; Makowski M; Nadolny P; Pillwein M; Suprin M; Turri S
    Ther Innov Regul Sci; 2021 Mar; 55(2):251-261. PubMed ID: 32885397
    [TBL] [Abstract][Full Text] [Related]  

  • 11. The revision of the ICH Good Clinical Practice guidelines: a missed opportunity?
    Ravinetto R
    Indian J Med Ethics; 2017; 2(4):255-259. PubMed ID: 28537222
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Evaluation of clinical trials by Ethics Committees in Germany--results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).
    Russ H; Busta S; Jost B; Bethke TD
    Ger Med Sci; 2015; 13():Doc02. PubMed ID: 25698912
    [TBL] [Abstract][Full Text] [Related]  

  • 13. The Good Clinical Practice guideline and its interpretation - perceptions of clinical trial teams in sub-Saharan Africa.
    Vischer N; Pfeiffer C; Joller A; Klingmann I; Ka A; Kpormegbe SK; Burri C
    Trop Med Int Health; 2016 Aug; 21(8):1040-1048. PubMed ID: 27260671
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Promoting good clinical practices in the conduct of clinical trials: experiences in the Department of Veterans Affairs Cooperative Studies Program.
    Sather MR; Raisch DW; Haakenson CM; Buckelew JM; Feussner JR;
    Control Clin Trials; 2003 Oct; 24(5):570-84. PubMed ID: 14500054
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency.
    Arango J; Chuck T; Ellenberg SS; Foltz B; Gorman C; Hinrichs H; McHale S; Merchant K; Seltzer J; Shapley S; Wild G
    Ther Innov Regul Sci; 2016 Jul; 50(4):480-486. PubMed ID: 27390628
    [TBL] [Abstract][Full Text] [Related]  

  • 16. It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North-South collaborative trials.
    Ravinetto R; Tinto H; Diro E; Okebe J; Mahendradhata Y; Rijal S; Gotuzzo E; Lutumba P; Nahum A; De Nys K; Casteels M; Boelaert M
    BMJ Glob Health; 2016; 1(3):e000122. PubMed ID: 28588969
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Ethical considerations in clinical trials: a critique of the ICH-GCP guideline.
    Kaur S; Choy CY
    Dev World Bioeth; 2014 Apr; 14(1):20-8. PubMed ID: 23170779
    [TBL] [Abstract][Full Text] [Related]  

  • 18. [New Japanese GCP--from the standpoint of a sponsor].
    Ebi O
    Gan To Kagaku Ryoho; 1998 Apr; 25(5):650-62. PubMed ID: 9571962
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Quality assurance of ethical issues and regulatory aspects relating to good clinical practices in the HELENA Cross-Sectional Study.
    Béghin L; Castera M; Manios Y; Gilbert CC; Kersting M; De Henauw S; Kafatos A; Gottrand F; Molnar D; Sjöström M; Leclercq C; Widhalm K; Mesana MI; Moreno LA; Libersa C;
    Int J Obes (Lond); 2008 Nov; 32 Suppl 5():S12-8. PubMed ID: 19011647
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Good Clinical Practice (GCP) - an alternative, unarticulated narrative.
    Malhotra S
    Indian J Med Ethics; 2022; VII(2):119-122. PubMed ID: 34730093
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.