Sponsor: [Name of sponsor] Nordic Trial Coordinater [If applicable] (NTC): National Coordinating [All the involved NCI in the Nordic countries] investigator (NCI): GCP Units [All other GCP Units involved will be listed here] The Communication Plan (CP) defines the regular communication activities that take place during the course of a clinical trial. The main purpose is to ensure that sponsor/national coordinating investigator or principal investigators and GCP monitors receive the information they need in a timely manner. This CP will not be applicable in the clinical trials where a sufficient Communication Plan is made by the sponsor. It is not a requirement to use the CP but a recommendation in the relevant cases. The CP is completed before the initiation of the clinical trial. The sponsor/national coordinating investigator is the owner of the document and is responsible for creating the document and updating the document during the trial whenever needed. The CP is distributed by the sponsor/national coordinating investigator to all the stakeholders as mentioned in the CP. The CP is placed in the sponsor and/or national coordinating investigators Trial Master File. The CP defines where documents should be filed during the course of the clinical trial in order to enable access to the trial documents for GCP monitors and investigators participating in the trial. The CP describes who is responsible for communicating particular information to whom and in what form. The CP defines an effective form of transferring information. The original plan is distributed to all stakeholders as mentioned in the CP. Additional persons should be considered. Updates are distributed to all concerned parties as mentioned in the CP.
Sponsor: [Name of sponsor] Nordic Trial Coordinater (NTC): [If applicable] National Coordinating investigator (NCI): [All the involved NCI in the Nordic countries] GCP Units [All other GCP Units involved will be listed here] The Communication Plan (CP) defines the regular communication activities that take place during the course of a clinical trial. The main purpose is to ensure that sponsor/national coordinating investigator or principal investigators and GCP monitors receive the information they need in a timely manner. This CP will not be applicable in the clinical trials where a sufficient Communication Plan is made by the sponsor. It is not a requirement to use the CP but a recommendation in the relevant cases. The CP is completed before the initiation of the clinical trial. The sponsor/national coordinating investigator is the owner of the document and is responsible for creating the document and updating the document during the trial whenever needed. The CP is distributed by the sponsor/national coordinating investigator to all the stakeholders as mentioned in the CP. The CP is placed in the sponsor and/or national coordinating investigators Trial Master File. The CP defines where documents should be filed during the course of the clinical trial in order to enable access to the trial documents for GCP monitors and investigators participating in the trial. The CP describes who is responsible for communicating particular information to whom and in what form. The CP defines an effective form of transferring information. The original plan is distributed to all stakeholders as mentioned in the CP. Additional persons should be considered. Updates are distributed to all concerned parties as mentioned in the CP.
NORM_Guideline_for_monitoring_version_5_24.10.2017.docx