Site SOPs 2010
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1. Responder Information

Thank you for completing this survey. We are excited to compile a list of SOPs that would be expected and desired for clinical research site to have.

When the results are complied you will be sent a final copy via e-mail, if you provide your e-mail address.

1. If you'd like a copy of these results when this survey is completed please provide your e-mail address.

If you'd like a copy of these results when this survey is completed please provide your e-mail address.

2. What type of a company do you work at?

What type of a company do you work at? Research Site

Sponsor

CRO

IRB

Federal Agency

Legal Firm

Consultant

Other

Other (please specify)

3. What position do you hold?

What position do you hold? Compliance Officer

Principal Investigator

Study Coordinator

Site Manager

Monitor

Auditor

Other

Other (please specify)

4. Indicate how important you believe each SOP is for a clinical research site to have.

	Must Have	Nice to Have	Not Critical to Have
Writing and revising SOPs	*Indicate how important you believe each SOP is for a clinical research site to have. Writing and revising SOPs Must Have	Writing and revising SOPs Nice to Have	Writing and revising SOPs Not Critical to Have
SOP glossary & appendix	SOP glossary & appendix Must Have	SOP glossary & appendix Nice to Have	SOP glossary & appendix Not Critical to Have
Preparation & maintenance of regulatory documents	Preparation & maintenance of regulatory documents Must Have	Preparation & maintenance of regulatory documents Nice to Have	Preparation & maintenance of regulatory documents Not Critical to Have
Completion of Form FDA 1572	Completion of Form FDA 1572 Must Have	Completion of Form FDA 1572 Nice to Have	Completion of Form FDA 1572 Not Critical to Have
Clinical research personnel CVs and licenses	Clinical research personnel CVs and licenses Must Have	Clinical research personnel CVs and licenses Nice to Have	Clinical research personnel CVs and licenses Not Critical to Have
Financial disclosure of reserach personnel	Financial disclosure of reserach personnel Must Have	Financial disclosure of reserach personnel Nice to Have	Financial disclosure of reserach personnel Not Critical to Have
Initial IRB submission	Initial IRB submission Must Have	Initial IRB submission Nice to Have	Initial IRB submission Not Critical to Have
Continuing review submission to the IRB	Continuing review submission to the IRB Must Have	Continuing review submission to the IRB Nice to Have	Continuing review submission to the IRB Not Critical to Have
Protocol amendment submission to the IRB	Protocol amendment submission to the IRB Must Have	Protocol amendment submission to the IRB Nice to Have	Protocol amendment submission to the IRB Not Critical to Have
Processing and reporting to the Sponsor & IRB protocol deviations	Processing and reporting to the Sponsor & IRB protocol deviations Must Have	Processing and reporting to the Sponsor & IRB protocol deviations Nice to Have	Processing and reporting to the Sponsor & IRB protocol deviations Not Critical to Have
Processing and reporting to the Sponsor & IRB Adverse Events and Serious Adverse Events	Processing and reporting to the Sponsor & IRB Adverse Events and Serious Adverse Events Must Have	Processing and reporting to the Sponsor & IRB Adverse Events and Serious Adverse Events Nice to Have	Processing and reporting to the Sponsor & IRB Adverse Events and Serious Adverse Events Not Critical to Have
Close out documentation to the IRB	Close out documentation to the IRB Must Have	Close out documentation to the IRB Nice to Have	Close out documentation to the IRB Not Critical to Have
Conflict of Interest of research personnel	Conflict of Interest of research personnel Must Have	Conflict of Interest of research personnel Nice to Have	Conflict of Interest of research personnel Not Critical to Have
Documenting of delegation of authority	Documenting of delegation of authority Must Have	Documenting of delegation of authority Nice to Have	Documenting of delegation of authority Not Critical to Have
Notes to File	Notes to File Must Have	Notes to File Nice to Have	Notes to File Not Critical to Have
Corrective and preventative actions plans and documentation	Corrective and preventative actions plans and documentation Must Have	Corrective and preventative actions plans and documentation Nice to Have	Corrective and preventative actions plans and documentation Not Critical to Have
Storage of regulatory documents	Storage of regulatory documents Must Have	Storage of regulatory documents Nice to Have	Storage of regulatory documents Not Critical to Have
Protocol feasibility assessment plan	Protocol feasibility assessment plan Must Have	Protocol feasibility assessment plan Nice to Have	Protocol feasibility assessment plan Not Critical to Have
Confidentially agreements and study questionnaires for new studies	Confidentially agreements and study questionnaires for new studies Must Have	Confidentially agreements and study questionnaires for new studies Nice to Have	Confidentially agreements and study questionnaires for new studies Not Critical to Have
Study budget	Study budget Must Have	Study budget Nice to Have	Study budget Not Critical to Have
Study contract	Study contract Must Have	Study contract Nice to Have	Study contract Not Critical to Have
Completing and maintaining case report forms	Completing and maintaining case report forms Must Have	Completing and maintaining case report forms Nice to Have	Completing and maintaining case report forms Not Critical to Have
Preparing and managing source data documentation	Preparing and managing source data documentation Must Have	Preparing and managing source data documentation Nice to Have	Preparing and managing source data documentation Not Critical to Have
Completion of common sponsor provided study forms	Completion of common sponsor provided study forms Must Have	Completion of common sponsor provided study forms Nice to Have	Completion of common sponsor provided study forms Not Critical to Have
Recording data & making corrections	Recording data & making corrections Must Have	Recording data & making corrections Nice to Have	Recording data & making corrections Not Critical to Have
Obtaining and documenting the Informed Consent process	Obtaining and documenting the Informed Consent process Must Have	Obtaining and documenting the Informed Consent process Nice to Have	Obtaining and documenting the Informed Consent process Not Critical to Have
Managing changes to the Informed Consent document with the IRB and study volunteers	Managing changes to the Informed Consent document with the IRB and study volunteers Must Have	Managing changes to the Informed Consent document with the IRB and study volunteers Nice to Have	Managing changes to the Informed Consent document with the IRB and study volunteers Not Critical to Have
General correspondence policy	General correspondence policy Must Have	General correspondence policy Nice to Have	General correspondence policy Not Critical to Have
Recruitment & retention of study volunteers	Recruitment & retention of study volunteers Must Have	Recruitment & retention of study volunteers Nice to Have	Recruitment & retention of study volunteers Not Critical to Have
Monitoring and managing study volunteer compliance	Monitoring and managing study volunteer compliance Must Have	Monitoring and managing study volunteer compliance Nice to Have	Monitoring and managing study volunteer compliance Not Critical to Have
Long term documentation storage	Long term documentation storage Must Have	Long term documentation storage Nice to Have	Long term documentation storage Not Critical to Have
Generic GCP training and responsibilities	Generic GCP training and responsibilities Must Have	Generic GCP training and responsibilities Nice to Have	Generic GCP training and responsibilities Not Critical to Have
Study specific training	Study specific training Must Have	Study specific training Nice to Have	Study specific training Not Critical to Have
Confidentiality of clinical trial information	Confidentiality of clinical trial information Must Have	Confidentiality of clinical trial information Nice to Have	Confidentiality of clinical trial information Not Critical to Have
On call or off hours policy	On call or off hours policy Must Have	On call or off hours policy Nice to Have	On call or off hours policy Not Critical to Have
Routine research meetings	Routine research meetings Must Have	Routine research meetings Nice to Have	Routine research meetings Not Critical to Have
Pre-Study visits	Pre-Study visits Must Have	Pre-Study visits Nice to Have	Pre-Study visits Not Critical to Have
Principal Investigator meetings	Principal Investigator meetings Must Have	Principal Investigator meetings Nice to Have	Principal Investigator meetings Not Critical to Have
Site Initiation Visit	Site Initiation Visit Must Have	Site Initiation Visit Nice to Have	Site Initiation Visit Not Critical to Have
Monitor visits	Monitor visits Must Have	Monitor visits Nice to Have	Monitor visits Not Critical to Have
Study close out visit	Study close out visit Must Have	Study close out visit Nice to Have	Study close out visit Not Critical to Have
Audits	Audits Must Have	Audits Nice to Have	Audits Not Critical to Have
Receiving, reconciliation & storing	Receiving, reconciliation & storing Must Have	Receiving, reconciliation & storing Nice to Have	Receiving, reconciliation & storing Not Critical to Have
Master IP list	Master IP list Must Have	Master IP list Nice to Have	Master IP list Not Critical to Have
Maintaining IP blinding codes and process to break the code	Maintaining IP blinding codes and process to break the code Must Have	Maintaining IP blinding codes and process to break the code Nice to Have	Maintaining IP blinding codes and process to break the code Not Critical to Have
Transportation of IP	Transportation of IP Must Have	Transportation of IP Nice to Have	Transportation of IP Not Critical to Have
Dispensing of IP	Dispensing of IP Must Have	Dispensing of IP Nice to Have	Dispensing of IP Not Critical to Have
Labeling IP	Labeling IP Must Have	Labeling IP Nice to Have	Labeling IP Not Critical to Have
Destroying IP	Destroying IP Must Have	Destroying IP Nice to Have	Destroying IP Not Critical to Have
Returning IP	Returning IP Must Have	Returning IP Nice to Have	Returning IP Not Critical to Have
E-signatures	E-signatures Must Have	E-signatures Nice to Have	E-signatures Not Critical to Have
Passwords	Passwords Must Have	Passwords Nice to Have	Passwords Not Critical to Have
OSHA regulations	OSHA regulations Must Have	OSHA regulations Nice to Have	OSHA regulations Not Critical to Have
Transporting hazardous goods - training & process	Transporting hazardous goods - training & process Must Have	Transporting hazardous goods - training & process Nice to Have	Transporting hazardous goods - training & process Not Critical to Have
Clinical research ethical code of conduct	Clinical research ethical code of conduct Must Have	Clinical research ethical code of conduct Nice to Have	Clinical research ethical code of conduct Not Critical to Have
Routine equipment maintenance & calibration	Routine equipment maintenance & calibration Must Have	Routine equipment maintenance & calibration Nice to Have	Routine equipment maintenance & calibration Not Critical to Have
Temperature monitoring	Temperature monitoring Must Have	Temperature monitoring Nice to Have	Temperature monitoring Not Critical to Have

5. Please list any SOPs that you think MUST be included in this list. Thank you!

Please list any SOPs that you think MUST be included in this list. Thank you!

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