Clinical Intervention Study Protocol Template PREFACE The Clinical Intervention Study Protocol Template is a suggested format for clinical trials sponsored by the National Center for Complementary and Integrative Health (NCCIH). Investigators are encouraged to use this format, as appropriate, when developing protocols for their studies. Large multi-site observational studies will also benefit from this protocol template. Note that instructions and explanatory text are indicated by italics and should be replaced in your protocol with appropriate text. Section headings and template text formatted in regular type should be included in your protocol document as provided in the template. The goal of this template is to provide a general format applicable to all single- and multicenter clinical intervention trials (e.g., drug, surgery, behavioral, nutritional, device, etc). As you can see the version number and date are on the bottom of each page. When making changes to an approved and provide a summary of the changes, with the “final” protocol, please date, at the front of the protocol.
Clinical Intervention Study Protocol Template PREFACE The Clinical Intervention Study Protocol Template is a suggested format for clinical trials sponsored by the National Center for Complementary and Integrative Health (NCCIH). Investigators are encouraged to use this format, as appropriate, when developing protocols for their studies. Large multi-site observational studies will also benefit from this protocol template. Note that instructions and explanatory text are indicated by italics and should be replaced in your protocol with appropriate text. Section headings and template text formatted in regular type should be included in your protocol document as provided in the template. The goal of this template is to provide a general format applicable to all single- and multicenter clinical intervention trials (e.g., drug, surgery, behavioral, nutritional, device, etc). As you can see the version number and date are on the bottom of each page. When making changes to an approved and “final” protocol, please provide a summary of the changes, with the date, at the front of the protocol.
ProtocolTemplate_NCCIH_07-17-2015.docx