Field 5. Primary Sponsor

  1. Field 5. Primary Sponsor
    1. WHO description
    2. Schema
    3. Validation
    4. Labels
    5. Sample Values
    6. Discussion

WHO description

The individual, organization, group or other legal entity which takes responsibility for initiating, managing and/or financing a study. The Primary Sponsor is responsible for ensuring that the trial is properly registered. The Primary Sponsor may or may not be the main funder.

Schema

(the value of this field will come from the trialist user record)

Validation

Labels

EN: Primary Sponsor

PT: Patrocinador

ES: Patrocinador

Sample Values

sample 1

sample 2

sample 3

Discussion

Executive Committee decisions (2009-08-06):

  • The sponsor will be represented by the individual user that represents an institution and/or group. The information related to the institution and/or group will be part of the user record.

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Definition of sponsor (ANVISA - rdc 39):

Art. 2° Entende-se como patrocinador a pessoa física ou jurídica, pública ou privada, que apóia financeiramente a pesquisa.

Art. 3º Além da provisão de recursos financeiros necessários para a condução de pesquisas clínicas nos centros de pesquisa localizados em território nacional, são atribuições do patrocinador:

(a) implementação e o acompanhamento das pesquisas clínicas;

b) garantia da correta condução do protocolo previamente aprovado pelas autoridades reguladoras competentes;

(c) a veracidade dos dados coletados e as demais atribuições que envolvam a garantia das "Boas Práticas Clínicas";

(d) o relato dos eventos adversos graves à ANVISA (via NOTIVISA).

§ 1° Para os estudos clínicos regulamentados pela presente norma e que são patrocinados por agências nacionais ou internacionais de fomento à pesquisa, entidades filantrópicas, organizações não governamentais (ONGs) ou outras entidades sem fins lucrativos, fica previsto que o(s) investigador(es) responsável(eis) pela coordenação da pesquisa assume perante a ANVISA o papel de representante do patrocinador, caso não haja uma ORPC responsável pela condução da mesma, devendo cumprir como representante do mesmo para todas as obrigações previstas no caput do presente artigo.

§ 2° No caso de estudos independentes, para os quais o investigador não conta com auxílio financeiro de um patrocinador específico, incluindo os casos em que recebe os medicamentos da pesquisa na forma de doação, onde o doador não deseja ser caracterizado como patrocinador do estudo, o investigador assume adicionalmente, as responsabilidades previstas no caput deste artigo.

Article 2: The sponsor is defined as individual or company, public or private, which financially supports the research. Article 3: In addition to the provision of financial resources necessary for the conduct of clinical research in the centers located in national territory, are tasks of the sponsor: (a) implementation and monitoring of clinical research; (b) ensuring the proper conduct of the protocol approved in advance by the relevant regulatory authorities; (c) the accuracy of the collected data and other tasks involving the security of "Good Clinical Practices"; (d) the reporting of serious adverse events to ANVISA (NOTIVISA - SYSTEM INFORMATIZED WHICH RECEIVE REPORTS OF ADVERSES EVENTS).

§ 1°- In clinical studies regulated by this rule and are sponsored by national or international agencies to promote the research, philanthropic entities, non-governmental organizations (NGOs) or other non-profit organizations, it is assumed that investigator is responsible for coordinating the search for ANVISA assumes the role of representative of the sponsor, if there is a ORPC responsible for the conduct of it, should meet as a representative of the same for all the obligations contained in the main body of this article.

§ 2° - In the case of independent studies, for which the investigator has no financial assistance from a specific sponsor, including cases in receiving the medicines of research in the form of donation where the donor does not want to be characterized as a sponsor of the study, the researcher additionally assume the responsibilities set out in the main body of this article. § 3° - For the cases referred to in the preceding paragraph, the researcher is now called "investigator-sponsor."

Question: should we classify the type of sponsor - industry, governmen agency, university/organization, other.

Part of: TrialRegistrationDataSet