Summary of Colombia INVIMA Requirements Checklist - Clinical Trials with Investigational Medical Devices - First_In_Human


1	Colombia INVIMA Requirements Checklist - Investigational Medical Devices
2	Clinical Trial Approval Process in Colombia
3			www.bioaccessla.com
4
5	Requirements Description

6		Investigational Medical Devices
7	1	Cover letter
8		1. Protocol code number
9		2. Protocol version and date
10		3. Investigator's brochure version and date
11		4. Protocol title
12		5. Phase of the study
13		6. Regions where the study is being conducted
14		7. List of countries (including Colombia) where the study is (or will be) conducted
15		8. Name of the investigational medical product
16		9. Control medical device (if applicable)
17		10. Therapeutic area of the study
18		11. Sample size (projected)
19		12. Sample size (current, worldwide)
20		13. Total number of subject that the Sponsor plans to enroll in Colombia
21		14. Number of subjects that the Sponsor plans to enroll in each clinical research site in Colombia
22		15. Total number of patients that will participate in the study (globally)
23		16. Duration of the study
24		17. Study start date (estimated, worldwide)
25		18. Study start date (estimated, Colombia)
26		19. Study end date (estimated)
27		20. Duration of the subject participation in the study
28		21. Insurance policy (number, issue and expiration date)
29		22. Participating clinical research sites or institutions
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31	2	Study Protocol
32	2.1	Study Summary
33	2.2	Problem Formulation
34		1. Problem justification
35		2. Proposal justification
36		3. Research questions
37	2.3	Theoretical and Conceptual Framework
38	2.4	Information about the Investigational Medical Device
39		1. Name, brand, reference number
40		2. Description
41		3. Use and indications
42		4. Label artwork
43		5. User's or insertion manual (as applicable)
44		6. Lab test results
45		1.	Biocompatibility, sterility, pyrogenicity, stability, performance, animal studies, etc. (as applicable)
46		2.	Electrical safety, electromagnetic compatibility, etc. (as applicable)
47		7. Software test results as applicable
48	2.5	Hypothesis (as applicable)
49	2.6	Objectives
50	2.7	Methodology
51		1. Type of Study
52		2. Demographics
53		3. Sampling
54		4. Inclusion and exclusion criteria
55		5. Table of variables
56		6. Information processing and analysis technique
57		7. Procedure description
58		8. Risk analysis plan, benefits, and risk mitigation. Risk analysis matrix.
59		9. Identification, analysis, and reporting of adverse events
60		10. Pilot trial (if applicable)
61		11. Prevention of errors and study bias
62		12. Technique for information processing and analysis
63	2.8	Bibliographic references (Vancouver System/ICMJE)
64
65	3	Investigator's Brochure
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67	4	Case report form(s)
68
69	5	Ethical Documents
70		1. Approval letter(s) from the local ethics committee for each of the participating research institutions (see item 7.1 for details)
71		2. Patient’s informed consent form (ICF).
72
73	6	Project Management Documents
74		2. Study budget
75		3. Insurance policy certificate.
76		4. Gantt chart/project timeline
77
78	7	Additional Documents
79		1. Clinical Supply List
80		2. Letter(s) of approval from the local ethics committee at the site(s) where the Sponsor plans to conduct the trial.
81		3. Original bank deposit slip for the payment of the applicable INVIMA fee (approx. USD $1000).
82		4. Academic credentials of the investigator(s):
83		1.	Investigator(s)' certificate of completion of Good Clinical Practice training
84		5. Helsinki Declaration letter(s). Bioaccess will provide this template letter.
85		6. Investigator(s)' acceptance letter. Bioaccess will provide this template letter.
86		7. Training certificate or letter issued by the Sponsor. Bioaccess will provide this template letter.
87		8. Acceptance letter from the Sponsor Bioaccess will provide this template letter.
88		9. Letter from the Sponsor transferring obligations to a local entity in Colombia. Bioaccess will provide this template letter.
89		10. Medical device disposal/destruction methods and guidelines.
90		11. Optional documents that are not required, but recommended to append to the submission if available from the Sponsor:
91		1.	Certificate of compliance with ISO 13485
92		2.	Statement of compliance in line with relevant essential requirements of Annex I of the European Medical Device Directive (93/42/EEC)
93		3.	If applicable, an statement regarding human blood derivatives (quality, safety, and usefulness of the substance as part of the device)
94		4.	If applicable, an statement regarding tissues of animal origin (risk management measures which have been applied to reduce the risk of infection)
95
96		Notes:	All documents must be translated to Spanish.
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