Clinical research sop templates

Ethics committee submissions checklist. Ethics committee approval letter template. Adverse Event Record. Safety assessment and reporting SOP. Adverse Event Log Template. Serious adverse events log. Non compliance to protocol SOP. SAE reporting checklist. Serious adverse events form template. Clinical trial agreement. Clinical trial agreement log. Confidentiality and NDA Template. Interviewer contract English.

Interviewer contract French. Regulatory binder table of contents. Monitoring checklist — internal. Monitoring activities Template.

Monitoring visits SOP. Monitoring agreement for local independent safety monitor template. Monitoring SOP. Monitoring plan template. Monitoring visit log. Protocol deviation log. Protocol training log. Protocol amendment assessment SOP. Protocol violation log. To share your own templates and SOPs, or comment on these, please email info globalhealthtrials. We look forward to hearing from you! Dear Joby.

Nobody has so far shared a research misconduct SOP on this site - why don't you try posting on the discussion forums go to "community" and then "groups" - and requesting one? However, a search on google did show a few which may be of use to you in the meanwhile.

For example:. Much appreciated, and I hope you found everything you needed for your SOP on research misconduct. I am delighted you found this website. I earlier introduced it to you because of your prolific interest in health care information and resource sharing Hi, I am new to this website and also to the Clinical Research Industry for that matter I only am able to see the PDF of these courses, just wanted to know are these audio lectures and also happen to have audio clips that go with the pdf?

Hi Nazish, and welcome to the Network. The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? If so - no problem! If you need anything else, do ask! Kind regards The Editorial Team. Thanks so much. These are very helpful seminars. Appreciate your help. Data Management. Statistical Analysis Plans for Clinical Trials. Good Documentation Practice. Deviations and Breaches.

MHRA Inspections. Urgent Safety Measures. Log of Breaches and Urgent Safety Measures. Suspected Serious Breaches. Research Project Closure. Research Project Publications and Dissemination.

Trial Master File Contents List. Archival of essential documents SOP. Archiving trial data SOP. Enrolment log. Screening SOP. Subject identification log template. Recruiting study participants SOP. Subject screening log template. Follow up visits SOP. Subject visit log vaccine trial. Pre and post admission study team meetings SOP.

Subject visit log any trial. Blood Sampling SOP. Subject withdrawal and termination log. Pre-screening eligibility check template. Transfer of patients SOP. Screening procedures. Interviewer recruitment log. Participant communication log. Interviewer follow up form. Partitipant Retention Plan. Informed consent template - generic. Audiovisual recording of informed consent SOP. Informed consent template for clinical trials. Reviewing and obtaining informed consent SOP. Informed consent template for observational in-patient clinical trials.

Informed consent template for interviewing research studies. Informed consent template sampling only. Monitoring informed consent checklist. Subject informed consent log template. AudioViual recording informed consent checklist. Opinion leader inputs - meeting records. Informed Consent Sample only in household community.

Concomitant medication log. Managing biological samples SOP. These should be utilized to enhance quality, efficiency, data reliability and patient safety. Diversity in trial design, study sponsor, therapeutic area, investigator and coordinator experience, etc. However, establishment and adherence to SOPs can ensure compliance to Good Clinical Practice guidelines and applicable federal regulations common to clinical research of all types.

The SOPs in this library define clinical research as: CLINICAL TRIAL CT : Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect s of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available.

Optional Resources If you need an example of a general training log, please see this link. A certificate to document review of each SOP can be obtained here.